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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Primary Purpose

Anaemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Daprodustat

Darbepoetin alfa

Placebo

Iron Therapy

About this trial

This is an interventional treatment trial for Anaemia focused on measuring GSK1278863, hemoglobin, anemia, non-dialysis, erythropoiesis stimulating agents, daprodustat, chronic kidney disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18 to 99 years of age (inclusive)
CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
>=80% and <=120% compliance with placebo during run-in period.
Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions.

Exclusion Criteria:

Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening.
Transferrin saturation (TSAT) (screening only): <=20%.
Aplasias: History of bone marrow aplasia or pure red cell aplasia.
Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1).
MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization (Day 1).
Stroke or transient ischemic attack: <=4 weeks prior to screening through to randomization (Day 1).
Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator.
Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.
Bilirubin: >1.5xULN at screening.
Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated >=4 weeks prior to screening.
Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa.
Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
Females only: Subject is pregnant [as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.
Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daprodustat

Darbepoetin alfa

Arm Description

Participants will receive oral daprodustat once daily.

Participants will be administered darbepoetin alfa subcutaneously (SC).

Outcomes

Primary Outcome Measures

Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)

Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied [*] number of participants with at least 1 event) divided by [/] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)

Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.

Secondary Outcome Measures

Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)

Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period

Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period

Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period

Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period

Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period.

Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period

Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period

Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period

Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)

Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant.

Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period

Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period

All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration >=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period

All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of >=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was >=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period

Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period

Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period

Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period

Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period

Time to first occurrence of chronic dialysis was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period

Time to first occurrence of kidney transplant were analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Change From Baseline in Post-randomization Hgb Levels at Week 52

Blood samples were collected from participants for Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions.

Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)

Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / [Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)].

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / [Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)].

Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis

Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52

SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value*time + treatment group*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented.

Change From Baseline in SBP, DBP, MAP at End of Treatment

SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented.

Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years

BP exacerbation event (based on post-dialysis) was defined as: SBP >= 25 millimeter of mercury (mmHg) increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the negative binomial model with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented.

Number of Participants With at Least One BP Exacerbation Event During Study

BP exacerbation was defined as: SBP >= 25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one BP exacerbation event is presented.

Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria

Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.

Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52

EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.

Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52

The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52

CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52

The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52

Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Full Information

NCT ID

NCT02876835

First Posted

August 19, 2016

Last Updated

April 12, 2022

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02876835

Brief Title

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Official Title

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

September 27, 2016 (Actual)

Primary Completion Date

April 19, 2021 (Actual)

Study Completion Date

April 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anaemia

Keywords

GSK1278863, hemoglobin, anemia, non-dialysis, erythropoiesis stimulating agents, daprodustat, chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3872 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daprodustat

Arm Type

Experimental

Arm Description

Participants will receive oral daprodustat once daily.

Arm Title

Darbepoetin alfa

Arm Type

Active Comparator

Arm Description

Participants will be administered darbepoetin alfa subcutaneously (SC).

Intervention Type

Drug

Intervention Name(s)

Daprodustat

Intervention Description

The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Intervention Description

The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Intervention Type

Drug

Intervention Name(s)

Iron Therapy

Intervention Description

Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.

Primary Outcome Measure Information:

Title

Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)

Description

Time Frame

Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)

Secondary Outcome Measure Information:

Title

Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for vital status follow-up time period

Title

Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period

Description

Time Frame

Up to 4.3 person-years for CV follow-up time period

Title

Change From Baseline in Post-randomization Hgb Levels at Week 52

Description

Time Frame

Baseline (Pre-dose on Day 1) and Week 52

Title

Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)

Description

Time Frame

Week 28 to Week 52

Title

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis

Description

Time Frame

Week 28 to Week 52

Title

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis

Description

Time Frame

Week 28 to Week 52

Title

Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis

Description

Time Frame

Week 28 to end of study (4.3 person-years for follow-up time period)

Title

Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis

Description

Time Frame

Week 28 to end of study (4.3 person-years for follow-up time period)

Title

Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52

Description

Time Frame

Baseline (Week -4) and Week 52

Title

Change From Baseline in SBP, DBP, MAP at End of Treatment

Description

Time Frame

Baseline (Week -4) and 51.1 months

Title

Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years

Description

Time Frame

Day 1 to end of treatment (51.1 months)

Title

Number of Participants With at Least One BP Exacerbation Event During Study

Description

Time Frame

Day 1 to end of treatment (51.1 months)

Title

Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria

Description

Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.

Time Frame

Day 1 to 51.1 months

Title

Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52

Description

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

Description

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52

Description

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

Description

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52

Description

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52

Description

Time Frame

Baseline (Pre-dose on Day 1) and Week 52

Title

Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52

Description

Time Frame

Baseline (Pre-dose on Day 1) and Week 52

Title

Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52

Description

Time Frame

Baseline (Day 1) and Weeks 8, 12, 28, 52

Title

Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52

Description

Time Frame

Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Title

Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52

Description

Time Frame

Baseline (Pre-dose on Day 1) and Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18 to 99 years of age (inclusive) CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula. Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization. For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL. >=80% and <=120% compliance with placebo during run-in period. Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions. Exclusion Criteria: Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1). Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1). Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening. Transferrin saturation (TSAT) (screening only): <=20%. Aplasias: History of bone marrow aplasia or pure red cell aplasia. Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1). MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization (Day 1). Stroke or transient ischemic attack: <=4 weeks prior to screening through to randomization (Day 1). Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system. Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator. Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm. Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening. Bilirubin: >1.5xULN at screening. Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated >=4 weeks prior to screening. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa. Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin). Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer). Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days. Females only: Subject is pregnant [as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options. Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

GSK Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85305

Country

United States

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

GSK Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

48201

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85745

Country

United States

Facility Name

GSK Investigational Site

City

Azusa

State/Province

California

ZIP/Postal Code

91702

Country

United States

Facility Name

GSK Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93308

Country

United States

Facility Name

GSK Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

GSK Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

GSK Investigational Site

City

Cudahy

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

GSK Investigational Site

City

El Centro

State/Province

California

ZIP/Postal Code

92243

Country

United States

Facility Name

GSK Investigational Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

GSK Investigational Site

City

Granada Hills

State/Province

California

ZIP/Postal Code

91344

Country

United States

Facility Name

GSK Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

GSK Investigational Site

City

La Palma

State/Province

California

ZIP/Postal Code

90623

Country

United States

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

GSK Investigational Site

City

Montebello

State/Province

California

ZIP/Postal Code

90640

Country

United States

Facility Name

GSK Investigational Site

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Facility Name

GSK Investigational Site

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

GSK Investigational Site

City

Simi Valley

State/Province

California

ZIP/Postal Code

93065

Country

United States

Facility Name

GSK Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

GSK Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

GSK Investigational Site

City

Middlebury

State/Province

Connecticut

ZIP/Postal Code

06762

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

GSK Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33189

Country

United States

Facility Name

GSK Investigational Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

GSK Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

GSK Investigational Site

City

Homestead

State/Province

Florida

ZIP/Postal Code

33033

Country

United States

Facility Name

GSK Investigational Site

City

Hudson

State/Province

Florida

ZIP/Postal Code

34667

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

GSK Investigational Site

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

Facility Name

GSK Investigational Site

City

Miami Gardens

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

GSK Investigational Site

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33150

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

GSK Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

GSK Investigational Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

GSK Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

GSK Investigational Site

City

Temple Terrace

State/Province

Florida

ZIP/Postal Code

33637

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

GSK Investigational Site

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60643

Country

United States

Facility Name

GSK Investigational Site

City

Crystal Lake

State/Province

Illinois

ZIP/Postal Code

60014

Country

United States

Facility Name

GSK Investigational Site

City

Mount Prospect

State/Province

Illinois

ZIP/Postal Code

60056

Country

United States

Facility Name

GSK Investigational Site

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

GSK Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

GSK Investigational Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

GSK Investigational Site

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

GSK Investigational Site

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

GSK Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

GSK Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

GSK Investigational Site

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

GSK Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

GSK Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70836

Country

United States

Facility Name

GSK Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

GSK Investigational Site

City

Potomac

State/Province

Maryland

ZIP/Postal Code

20854

Country

United States

Facility Name

GSK Investigational Site

City

Takoma Park

State/Province

Maryland

ZIP/Postal Code

20912-6385

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

GSK Investigational Site

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Facility Name

GSK Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

GSK Investigational Site

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63106

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

North Platte

State/Province

Nebraska

ZIP/Postal Code

69101

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

GSK Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

GSK Investigational Site

City

Flushing

State/Province

New York

ZIP/Postal Code

11355

Country

United States

Facility Name

GSK Investigational Site

City

Laurelton

State/Province

New York

ZIP/Postal Code

11413

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

GSK Investigational Site

City

Ridgewood

State/Province

New York

ZIP/Postal Code

11385

Country

United States

Facility Name

GSK Investigational Site

City

Yonkers

State/Province

New York

ZIP/Postal Code

10704

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

GSK Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Grand Forks

State/Province

North Dakota

ZIP/Postal Code

58201

Country

United States

Facility Name

GSK Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

15212

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

GSK Investigational Site

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

GSK Investigational Site

City

Lawton

State/Province

Oklahoma

ZIP/Postal Code

73505

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

GSK Investigational Site

City

Roseburg

State/Province

Oregon

ZIP/Postal Code

97471

Country

United States

Facility Name

GSK Investigational Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

GSK Investigational Site

City

Doylestown

State/Province

Pennsylvania

ZIP/Postal Code

18901

Country

United States

Facility Name

GSK Investigational Site

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17601

Country

United States

Facility Name

GSK Investigational Site

City

Upland

State/Province

Pennsylvania

ZIP/Postal Code

19013

Country

United States

Facility Name

GSK Investigational Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

GSK Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29209

Country

United States

Facility Name

GSK Investigational Site

City

Sumter

State/Province

South Carolina

ZIP/Postal Code

29150

Country

United States

Facility Name

GSK Investigational Site

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

GSK Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

GSK Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76002

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78751

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

GSK Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

GSK Investigational Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75237

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77043

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

GSK Investigational Site

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

GSK Investigational Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78202

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

GSK Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

GSK Investigational Site

City

Waxahachie

State/Province

Texas

ZIP/Postal Code

75165

Country

United States

Facility Name

GSK Investigational Site

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22304

Country

United States

Facility Name

GSK Investigational Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22033

Country

United States

Facility Name

GSK Investigational Site

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

GSK Investigational Site

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

GSK Investigational Site

City

Bluefield

State/Province

West Virginia

ZIP/Postal Code

24701

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Evita

State/Province

Buenos Aires

ZIP/Postal Code

B1778IFA

Country

Argentina

Facility Name

GSK Investigational Site

City

Coronel Suarez

State/Province

Buenos Aires

ZIP/Postal Code

7540

Country

Argentina

Facility Name

GSK Investigational Site

City

Junín

State/Province

Buenos Aires

ZIP/Postal Code

B6000GMA

Country

Argentina

Facility Name

GSK Investigational Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

GSK Investigational Site

City

Pergamino

State/Province

Buenos Aires

ZIP/Postal Code

B2700CPM

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

State/Province

Córdova

ZIP/Postal Code

5000

Country

Argentina

Facility Name

GSK Investigational Site

City

Córdoba

State/Province

Córdova

ZIP/Postal Code

5000

Country

Argentina

Facility Name

GSK Investigational Site

City

Córdoba

State/Province

Córdova

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

CP1431FWO

Country

Argentina

Facility Name

GSK Investigational Site

City

Corrientes

ZIP/Postal Code

W3400AMZ

Country

Argentina

Facility Name

GSK Investigational Site

City

Formosa

ZIP/Postal Code

P3600LLD

Country

Argentina

Facility Name

GSK Investigational Site

City

La Plata

ZIP/Postal Code

B1902COS

Country

Argentina

Facility Name

GSK Investigational Site

City

Mendoza

ZIP/Postal Code

M5500AFA

Country

Argentina

Facility Name

GSK Investigational Site

City

Moron

ZIP/Postal Code

B1708DPO

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucumán

ZIP/Postal Code

T4000AHL

Country

Argentina

Facility Name

GSK Investigational Site

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

GSK Investigational Site

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

GSK Investigational Site

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

GSK Investigational Site

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Facility Name

GSK Investigational Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

GSK Investigational Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

GSK Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

GSK Investigational Site

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

GSK Investigational Site

City

Nambour

State/Province

Queensland

ZIP/Postal Code

4560

Country

Australia

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

GSK Investigational Site

City

Reservoir

State/Province

Victoria

ZIP/Postal Code

3073

Country

Australia

Facility Name

GSK Investigational Site

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Liverpool

ZIP/Postal Code

2107

Country

Australia

Facility Name

GSK Investigational Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

GSK Investigational Site

City

Baudour

ZIP/Postal Code

7331

Country

Belgium

Facility Name

GSK Investigational Site

City

Brugge

ZIP/Postal Code

8310

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Ieper

ZIP/Postal Code

8900

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

GSK Investigational Site

City

Ronse

ZIP/Postal Code

9600

Country

Belgium

Facility Name

GSK Investigational Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

GSK Investigational Site

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40415-065

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80440-020

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80730-150

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

CEP 80230-130

Country

Brazil

Facility Name

GSK Investigational Site

City

Passo Fundo

State/Province

Rio Grande Do Sul

ZIP/Postal Code

99010-080

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-074

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Sao Jose do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Votuporanga

State/Province

São Paulo

ZIP/Postal Code

15500-003

Country

Brazil

Facility Name

GSK Investigational Site

City

Belo Horizonte

ZIP/Postal Code

30150-320

Country

Brazil

Facility Name

GSK Investigational Site

City

Brasilia

ZIP/Postal Code

70840-901

Country

Brazil

Facility Name

GSK Investigational Site

City

Feira de Santana

ZIP/Postal Code

44001-465

Country

Brazil

Facility Name

GSK Investigational Site

City

Joinville

ZIP/Postal Code

89201-010

Country

Brazil

Facility Name

GSK Investigational Site

City

Juiz De Fora

ZIP/Postal Code

36036-330

Country

Brazil

Facility Name

GSK Investigational Site

City

Sao Paulo

ZIP/Postal Code

01323-001

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

01323903

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04005-000

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04039-000

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

GSK Investigational Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Lom

ZIP/Postal Code

3600

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Smolyan

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V8

Country

Canada

Facility Name

GSK Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4V 1P1

Country

Canada

Facility Name

GSK Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 5T2

Country

Canada

Facility Name

GSK Investigational Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

GSK Investigational Site

City

Barranquilla

ZIP/Postal Code

760002

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogotá

ZIP/Postal Code

111711

Country

Colombia

Facility Name

GSK Investigational Site

City

Cali

ZIP/Postal Code

760007

Country

Colombia

Facility Name

GSK Investigational Site

City

Floridablanca

ZIP/Postal Code

681001

Country

Colombia

Facility Name

GSK Investigational Site

City

Medellin

ZIP/Postal Code

050012

Country

Colombia

Facility Name

GSK Investigational Site

City

Beroun

ZIP/Postal Code

26601

Country

Czechia

Facility Name

GSK Investigational Site

City

Cesky Krumlov

ZIP/Postal Code

38127

Country

Czechia

Facility Name

GSK Investigational Site

City

Ivancice

ZIP/Postal Code

664 95

Country

Czechia

Facility Name

GSK Investigational Site

City

Jilemnice

ZIP/Postal Code

514 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Marianske Lazne

ZIP/Postal Code

353 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Novy Jicin

ZIP/Postal Code

74101

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

53203

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

GSK Investigational Site

City

Sokolov

ZIP/Postal Code

356 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

GSK Investigational Site

City

Holstebro

ZIP/Postal Code

7500

Country

Denmark

Facility Name

GSK Investigational Site

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

GSK Investigational Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

GSK Investigational Site

City

Jämejala Village

ZIP/Postal Code

71024

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

EE-13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50501

Country

Estonia

Facility Name

GSK Investigational Site

City

Annonay

ZIP/Postal Code

07103

Country

France

Facility Name

GSK Investigational Site

City

Boulogne Billancourt

ZIP/Postal Code

92100

Country

France

Facility Name

GSK Investigational Site

City

Caen Cedex 9

ZIP/Postal Code

14033

Country

France

Facility Name

GSK Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Facility Name

GSK Investigational Site

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

GSK Investigational Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

GSK Investigational Site

City

Mulhouse

ZIP/Postal Code

68100

Country

France

Facility Name

GSK Investigational Site

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

GSK Investigational Site

City

Saint-Ouen

ZIP/Postal Code

93400

Country

France

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

GSK Investigational Site

City

Cloppenburg

State/Province

Niedersachsen

ZIP/Postal Code

49661

Country

Germany

Facility Name

GSK Investigational Site

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40210

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

GSK Investigational Site

City

Kaiserslautern

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67655

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04129

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

GSK Investigational Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

GSK Investigational Site

City

Alexandroupolis

ZIP/Postal Code

68100

Country

Greece

Facility Name

GSK Investigational Site

City

Arta

ZIP/Postal Code

471 00

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 26

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

GSK Investigational Site

City

Heraklion-Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

GSK Investigational Site

City

Ioannina

ZIP/Postal Code

45001

Country

Greece

Facility Name

GSK Investigational Site

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

GSK Investigational Site

City

Komotini

ZIP/Postal Code

69100

Country

Greece

Facility Name

GSK Investigational Site

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

GSK Investigational Site

City

Melissia

ZIP/Postal Code

15127

Country

Greece

Facility Name

GSK Investigational Site

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

546 42

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

551 34

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

GSK Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Lai Chi kok

Country

Hong Kong

Facility Name

GSK Investigational Site

City

New Territories

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Tsuen Wan

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

GSK Investigational Site

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

GSK Investigational Site

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

GSK Investigational Site

City

Kecskemét

ZIP/Postal Code

6000

Country

Hungary

Facility Name

GSK Investigational Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

GSK Investigational Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

GSK Investigational Site

City

Salgótarján

ZIP/Postal Code

3100

Country

Hungary

Facility Name

GSK Investigational Site

City

Szigetvar

ZIP/Postal Code

7900

Country

Hungary

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380054

Country

India

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380059

Country

India

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560054

Country

India

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560055

Country

India

Facility Name

GSK Investigational Site

City

Calicut

ZIP/Postal Code

673008

Country

India

Facility Name

GSK Investigational Site

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Facility Name

GSK Investigational Site

City

Chennai, Tamil Nadu

ZIP/Postal Code

600 006

Country

India

Facility Name

GSK Investigational Site

City

Chennai

ZIP/Postal Code

600037

Country

India

Facility Name

GSK Investigational Site

City

Delhi

ZIP/Postal Code

110076

Country

India

Facility Name

GSK Investigational Site

City

Ghaziabad

ZIP/Postal Code

201012

Country

India

Facility Name

GSK Investigational Site

City

Gurgaon

ZIP/Postal Code

122001

Country

India

Facility Name

GSK Investigational Site

City

Hyderabad

ZIP/Postal Code

500012

Country

India

Facility Name

GSK Investigational Site

City

Hyderabad

ZIP/Postal Code

500034

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302004

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302018

Country

India

Facility Name

GSK Investigational Site

City

Lucknow

ZIP/Postal Code

226014

Country

India

Facility Name

GSK Investigational Site

City

Manipal

ZIP/Postal Code

576104

Country

India

Facility Name

GSK Investigational Site

City

Mumbai

ZIP/Postal Code

400008

Country

India

Facility Name

GSK Investigational Site

City

Mumbai

ZIP/Postal Code

400016

Country

India

Facility Name

GSK Investigational Site

City

Nadiad

ZIP/Postal Code

387001

Country

India

Facility Name

GSK Investigational Site

City

Nagpur

ZIP/Postal Code

440010

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110002

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110025

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411004

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411033

Country

India

Facility Name

GSK Investigational Site

City

Secunderabad

ZIP/Postal Code

560020

Country

India

Facility Name

GSK Investigational Site

City

Trivandrum

ZIP/Postal Code

695011

Country

India

Facility Name

GSK Investigational Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

GSK Investigational Site

City

Hadera

ZIP/Postal Code

PO Box 169

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

GSK Investigational Site

City

Nazareth

ZIP/Postal Code

16100

Country

Israel

Facility Name

GSK Investigational Site

City

Poriya

ZIP/Postal Code

15208

Country

Israel

Facility Name

GSK Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

GSK Investigational Site

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

GSK Investigational Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

GSK Investigational Site

City

Piacenza

State/Province

Emilia-Romagna

ZIP/Postal Code

29100

Country

Italy

Facility Name

GSK Investigational Site

City

Reggio Emilia

State/Province

Emilia-Romagna

ZIP/Postal Code

42123

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Lecco

State/Province

Lombardia

ZIP/Postal Code

23900

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

GSK Investigational Site

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10154

Country

Italy

Facility Name

GSK Investigational Site

City

Foggia

State/Province

Puglia

ZIP/Postal Code

71100

Country

Italy

Facility Name

GSK Investigational Site

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09100

Country

Italy

Facility Name

GSK Investigational Site

City

Imola

ZIP/Postal Code

40026

Country

Italy

Facility Name

GSK Investigational Site

City

Mestre

ZIP/Postal Code

30122

Country

Italy

Facility Name

GSK Investigational Site

City

Anyang-Si, Gyeonggi-do

ZIP/Postal Code

14068

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Bucheon

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Busan

ZIP/Postal Code

48108

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

41931

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Goyang-si

ZIP/Postal Code

10444

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Ilsanseo-gu, Goyang-si,

ZIP/Postal Code

10380

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

021431

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Jeonju-si

ZIP/Postal Code

54987

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

05355

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Uijeongbu-si

ZIP/Postal Code

11765

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Wonju-si

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Alor Setar

ZIP/Postal Code

55600

Country

Malaysia

Facility Name

GSK Investigational Site

City

Ipoh

ZIP/Postal Code

30450

Country

Malaysia

Facility Name

GSK Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

50603

Country

Malaysia

Facility Name

GSK Investigational Site

City

Kuantan

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

GSK Investigational Site

City

Lumut

ZIP/Postal Code

32040

Country

Malaysia

Facility Name

GSK Investigational Site

City

Pahang

ZIP/Postal Code

28000

Country

Malaysia

Facility Name

GSK Investigational Site

City

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

GSK Investigational Site

City

Saltillo

State/Province

Coahuila

ZIP/Postal Code

CP 25230

Country

Mexico

Facility Name

GSK Investigational Site

City

Torreon

State/Province

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

GSK Investigational Site

City

Durango.

State/Province

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

GSK Investigational Site

City

Ciudad De Mexico

State/Province

Estado De México

ZIP/Postal Code

14080

Country

Mexico

Facility Name

GSK Investigational Site

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37530

Country

Mexico

Facility Name

GSK Investigational Site

City

León

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara.

State/Province

Jalisco

ZIP/Postal Code

44600

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44620

Country

Mexico

Facility Name

GSK Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62448

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64000

Country

Mexico

Facility Name

GSK Investigational Site

City

Queretaro

State/Province

Querétaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

GSK Investigational Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80200

Country

Mexico

Facility Name

GSK Investigational Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80230

Country

Mexico

Facility Name

GSK Investigational Site

City

Mazatlán

State/Province

Sinaloa

ZIP/Postal Code

82020

Country

Mexico

Facility Name

GSK Investigational Site

City

Merida

State/Province

Yucatán

ZIP/Postal Code

97133

Country

Mexico

Facility Name

GSK Investigational Site

City

Merida

State/Province

Yucatán

ZIP/Postal Code

CP 97070

Country

Mexico

Facility Name

GSK Investigational Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

GSK Investigational Site

City

Chihuahua

ZIP/Postal Code

31203

Country

Mexico

Facility Name

GSK Investigational Site

City

Chihuahua

ZIP/Postal Code

31217

Country

Mexico

Facility Name

GSK Investigational Site

City

Ciudad De México

ZIP/Postal Code

03800

Country

Mexico

Facility Name

GSK Investigational Site

City

Ciudad De México

ZIP/Postal Code

06100

Country

Mexico

Facility Name

GSK Investigational Site

City

Culiacan

ZIP/Postal Code

80030

Country

Mexico

Facility Name

GSK Investigational Site

City

Tlalnepantla De Baz

ZIP/Postal Code

54055

Country

Mexico

Facility Name

GSK Investigational Site

City

Veracruz

ZIP/Postal Code

91020

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan, Jalisco

ZIP/Postal Code

45030

Country

Mexico

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Dunedin

ZIP/Postal Code

9016

Country

New Zealand

Facility Name

GSK Investigational Site

City

Hamilton

ZIP/Postal Code

2001

Country

New Zealand

Facility Name

GSK Investigational Site

City

Hastings

ZIP/Postal Code

4156

Country

New Zealand

Facility Name

GSK Investigational Site

City

Otahuhu

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

GSK Investigational Site

City

Takapuna, Auckland

ZIP/Postal Code

0740

Country

New Zealand

Facility Name

GSK Investigational Site

City

Baguio City, Benguet

ZIP/Postal Code

2600

Country

Philippines

Facility Name

GSK Investigational Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

GSK Investigational Site

City

Dasmarinas

ZIP/Postal Code

4114

Country

Philippines

Facility Name

GSK Investigational Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

GSK Investigational Site

City

Pasig

ZIP/Postal Code

1605

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

1500

Country

Philippines

Facility Name

GSK Investigational Site

City

Sto Tomas

ZIP/Postal Code

4234

Country

Philippines

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

GSK Investigational Site

City

Brzeg

ZIP/Postal Code

49301

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-027

Country

Poland

Facility Name

GSK Investigational Site

City

Kielce

ZIP/Postal Code

25-736

Country

Poland

Facility Name

GSK Investigational Site

City

Kolobrzeg

ZIP/Postal Code

78-100

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

92-213

Country

Poland

Facility Name

GSK Investigational Site

City

Radom

ZIP/Postal Code

26-610

Country

Poland

Facility Name

GSK Investigational Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

GSK Investigational Site

City

Zyrardow

ZIP/Postal Code

96-300

Country

Poland

Facility Name

GSK Investigational Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

GSK Investigational Site

City

Aveiro

ZIP/Postal Code

3814-501

Country

Portugal

Facility Name

GSK Investigational Site

City

Covilhã

ZIP/Postal Code

6200-000

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1069-166

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1250-189

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1400-195

Country

Portugal

Facility Name

GSK Investigational Site

City

Torres Novas

ZIP/Postal Code

2350-754

Country

Portugal

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

042122

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

GSK Investigational Site

City

Oradea

ZIP/Postal Code

410469

Country

Romania

Facility Name

GSK Investigational Site

City

Timisoara

ZIP/Postal Code

300723

Country

Romania

Facility Name

GSK Investigational Site

City

Irkutsk

ZIP/Postal Code

664049

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650060

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnodar

ZIP/Postal Code

350029

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

119121

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Mytischi

ZIP/Postal Code

141009

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Omsk

ZIP/Postal Code

644112

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Podolsk

ZIP/Postal Code

142110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

194104

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Volzhsky

ZIP/Postal Code

404120

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

768828

Country

Singapore

Facility Name

GSK Investigational Site

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6001

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town.

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

GSK Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

GSK Investigational Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08011

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Burela

ZIP/Postal Code

27880

Country

Spain

Facility Name

GSK Investigational Site

City

Caceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

GSK Investigational Site

City

Ciudad Real

ZIP/Postal Code

13002

Country

Spain

Facility Name

GSK Investigational Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

GSK Investigational Site

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

GSK Investigational Site

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Mollet del Valles

ZIP/Postal Code

08100

Country

Spain

Facility Name

GSK Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-141 86

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-75185

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-701 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

GSK Investigational Site

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Facility Name

GSK Investigational Site

City

New Taipei

ZIP/Postal Code

220

Country

Taiwan

Facility Name

GSK Investigational Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

116

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan Hsien

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Bangkoknoi

ZIP/Postal Code

10700

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

11000

Country

Thailand

Facility Name

GSK Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

GSK Investigational Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

GSK Investigational Site

City

Pathumthani

ZIP/Postal Code

12120

Country

Thailand

Facility Name

GSK Investigational Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

GSK Investigational Site

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

GSK Investigational Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

GSK Investigational Site

City

Eskisehir

ZIP/Postal Code

26480

Country

Turkey

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34130

Country

Turkey

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34381

Country

Turkey

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34899

Country

Turkey

Facility Name

GSK Investigational Site

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

GSK Investigational Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

GSK Investigational Site

City

Chernihiv

ZIP/Postal Code

14029

Country

Ukraine

Facility Name

GSK Investigational Site

City

Chernivtsi

ZIP/Postal Code

58005

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kherson

ZIP/Postal Code

73039

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kiev

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

01014

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

01023

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04112

Country

Ukraine

Facility Name

GSK Investigational Site

City

Lutsk

ZIP/Postal Code

43000

Country

Ukraine

Facility Name

GSK Investigational Site

City

Mykolaiv

ZIP/Postal Code

54058

Country

Ukraine

Facility Name

GSK Investigational Site

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhzhia

ZIP/Postal Code

69001

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

GSK Investigational Site

City

Stevenage

State/Province

Hertfordshire

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Hampstead

State/Province

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wolverhampton

State/Province

West Midlands

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Derby

ZIP/Postal Code

DE22 3NE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Doncaster

ZIP/Postal Code

DN2 5LT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Fife

ZIP/Postal Code

KY2 5AH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Glasgow.

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Ha Noi City

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

GSK Investigational Site

City

Ha Noi

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

GSK Investigational Site

City

Hai Phong

ZIP/Postal Code

180000

Country

Vietnam

Facility Name

GSK Investigational Site

City

Hanoi

ZIP/Postal Code

11000

Country

Vietnam

Facility Name

GSK Investigational Site

City

Ho Chi Minh City

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

GSK Investigational Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

34739196

Citation

Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.

Results Reference

background

PubMed Identifier

34865143

Citation

Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.

Results Reference

background

PubMed Identifier

36005278

Citation

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Results Reference

derived

Learn more about this trial

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Anaemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial