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

Primary Purpose

Anaemia, Aspergillosis, Allergic Bronchopulmonary

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Daprodustat

rhEPO

Placebo

Iron therapy

About this trial

This is an interventional treatment trial for Anaemia focused on measuring erythropoiesis stimulating agents, GSK1278863, daprodustat, anemia, chronic kidney disease, hemoglobin, recombinant human erythropoietin

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).
Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb >11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
Frequency of Dialysis: Hemodialysis (HD) >=2 times/week and peritoneal dialysis (PD) >=5 times/week. Home hemodialysis >=2 times/week.
Compliance with placebo [randomization (Day 1) only]: >=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 listed in the consent form and in this protocol.

Exclusion Criteria:

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 that would contraindicate the use of recombinant human erythropoietin (rhEPO).
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 QT 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 epoetin alfa 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).
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 serum 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 listed in the List of Highly Effective Methods for Avoiding Pregnancy.
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 rhEPO) 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

rhEPO

Arm Description

Participants will receive oral daprodustat once daily.

Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).

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 the 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, dialysis type 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 by [*] 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 Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52)

Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, missing post-Baseline hemoglobin 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.

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, dialysis type 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, dialysis type 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, dialysis type 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.

Mean Average Monthly On-treatment IV Iron Dose Per Participant

Average monthly IV iron dose (milligrams) per participant from Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from treatment start date + 1 to the earliest of (Week 52 visit date, first blood (red blood cell [RBC] or whole blood) transfusion date, and treatment stop date + 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. This total IV iron dose was divided by (the number of days from treatment start date + 1 to the earliest of (Week 52 visit date, first blood transfusion date (RBC or whole blood), and treatment stop date +1) / 30.4375 days). This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

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, dialysis type 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 for 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, dialysis type 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, dialysis type 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, dialysis type 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, dialysis type 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) 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, dialysis type 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 eCRF with hospitalization duration of >=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was >=24 hours. Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. Incidence rate per 100person 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 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, dialysis type 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, dialysis type 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, dialysis type 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 Hemoglobin Levels at Week 52

Blood samples were collected from participants for hemoglobin measurements. 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 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, dialysis type, region, Baseline hemoglobin and Baseline hemoglobin 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. Hemoglobin 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 Hemoglobin 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 Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis

Percentage of Time With Hemoglobin 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 semi-supine or seated position in the dialysis chair 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 + dialysis type + 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 semi-supine or seated position in the dialysis chair 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. This analysis was carried out by using ANCOVA model with terms for treatment group, dialysis type, 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 was defined (based on post-dialysis) 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, dialysis type 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 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 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, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning (Social fun), physical functioning (Phy. fun) 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 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-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.

Change From Baseline in On-Treatment EuroQol 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 health one can imagine and 100 represents the best health one can imagine. 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 worse outcome. 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.

Full Information

NCT ID

NCT02879305

First Posted

August 22, 2016

Last Updated

November 5, 2021

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02879305

Brief Title

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

Official Title

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 28, 2016 (Actual)

Primary Completion Date

November 9, 2020 (Actual)

Study Completion Date

November 9, 2020 (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 participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.

6. Conditions and Keywords

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

Anaemia, Aspergillosis, Allergic Bronchopulmonary

Keywords

erythropoiesis stimulating agents, GSK1278863, daprodustat, anemia, chronic kidney disease, hemoglobin, recombinant human erythropoietin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2964 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daprodustat

Arm Type

Experimental

Arm Description

Participants will receive oral daprodustat once daily.

Arm Title

rhEPO

Arm Type

Active Comparator

Arm Description

Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).

Intervention Type

Drug

Intervention Name(s)

Daprodustat

Intervention Description

Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.

Intervention Type

Drug

Intervention Name(s)

rhEPO

Intervention Description

The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.

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 3.9 person-years for CV follow-up time period

Title

Mean Change From Baseline in Hemoglobin (Hgb) Levels During 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 3.9 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 3.9 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 3.9 person-years for CV follow-up time period

Title

Mean Average Monthly On-treatment IV Iron Dose Per Participant

Description

Time Frame

Day 1 to Week 52

Title

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

Description

Time Frame

Up to 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 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 3.9 person-years for CV follow-up time period

Title

Change From Baseline in Post-randomization Hemoglobin 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 Hemoglobin 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 Hemoglobin 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 Hemoglobin 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 (3.9 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 (3.9 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 45.1 months

Title

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

Description

Time Frame

Day 1 to end of study (3.9 person-years for follow-up time period)

Title

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

Description

Time Frame

Day 1 to end of study (3.9 person-years for follow-up time period)

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 45.1 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 EuroQol 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 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

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). Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization. Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb >11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose. Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1). Frequency of Dialysis: Hemodialysis (HD) >=2 times/week and peritoneal dialysis (PD) >=5 times/week. Home hemodialysis >=2 times/week. Compliance with placebo [randomization (Day 1) only]: >=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 listed in the consent form and in this protocol. Exclusion Criteria: 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 that would contraindicate the use of recombinant human erythropoietin (rhEPO). 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 QT 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 epoetin alfa 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). 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 serum 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 listed in the List of Highly Effective Methods for Avoiding Pregnancy. 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 rhEPO) 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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

GSK Investigational Site

City

Pine Bluff

State/Province

Arkansas

ZIP/Postal Code

71603

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

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

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

GSK Investigational Site

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

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

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

Fairfield

State/Province

California

ZIP/Postal Code

94534

Country

United States

Facility Name

GSK Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91205

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

Hacienda Heights

State/Province

California

ZIP/Postal Code

91745

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

Lakewood

State/Province

California

ZIP/Postal Code

90712

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

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

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

Lynwood

State/Province

California

ZIP/Postal Code

60262

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

Monterey Park

State/Province

California

ZIP/Postal Code

91754

Country

United States

Facility Name

GSK Investigational Site

City

Moreno Valley

State/Province

California

ZIP/Postal Code

92553

Country

United States

Facility Name

GSK Investigational Site

City

Norco

State/Province

California

ZIP/Postal Code

92860

Country

United States

Facility Name

GSK Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

GSK Investigational Site

City

Ontario

State/Province

California

ZIP/Postal Code

91762

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92501

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

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

Santa Clarita

State/Province

California

ZIP/Postal Code

91387

Country

United States

Facility Name

GSK Investigational Site

City

Simi Valley

State/Province

California

ZIP/Postal Code

93065-091

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

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

GSK Investigational Site

City

Yorba Linda

State/Province

California

ZIP/Postal Code

92886

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

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

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

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

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

33150

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

Ocala

State/Province

Florida

ZIP/Postal Code

34471

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

Spring Hill

State/Province

Florida

ZIP/Postal Code

34608

Country

United States

Facility Name

GSK Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

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

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

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

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

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

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

Merrillville

State/Province

Indiana

ZIP/Postal Code

46410

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

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

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

Greenbelt

State/Province

Maryland

ZIP/Postal Code

20770

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

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

Roseville

State/Province

Michigan

ZIP/Postal Code

48066

Country

United States

Facility Name

GSK Investigational Site

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39501

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

Florissant

State/Province

Missouri

ZIP/Postal Code

63033

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

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

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89107

Country

United States

Facility Name

GSK Investigational Site

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

3801

Country

United States

Facility Name

GSK Investigational Site

City

Gallup

State/Province

New Mexico

ZIP/Postal Code

87301

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

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

Mineola

State/Province

New York

ZIP/Postal Code

11501

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

10710

Country

United States

Facility Name

GSK Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

GSK Investigational Site

City

Clyde

State/Province

North Carolina

ZIP/Postal Code

28721

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

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Facility Name

GSK Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

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

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

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

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

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37924

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

Beaumont

State/Province

Texas

ZIP/Postal Code

77701

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

77030

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78221

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

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

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

Shorewood

State/Province

Wisconsin

ZIP/Postal Code

53211

Country

United States

Facility Name

GSK Investigational Site

City

Burzaco

State/Province

Buenos Aires

ZIP/Postal Code

B1852FZD

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Evita

State/Province

Buenos Aires

ZIP/Postal Code

B1778IFA

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

Pilar

State/Province

Buenos Aires

ZIP/Postal Code

1629

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

Formosa

ZIP/Postal Code

P3600LLD

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

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

GSK Investigational Site

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2750

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

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

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

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

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

Birtinya

State/Province

Queensland

ZIP/Postal Code

4575

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

GSK Investigational Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

GSK Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

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

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

GSK Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

GSK Investigational Site

City

St. Pölten

ZIP/Postal Code

3100

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

A-1130

Country

Austria

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

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

GSK Investigational Site

City

Hasselt

ZIP/Postal Code

3500

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

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

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

90610-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

89227-680

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

Belo Horizonte, Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

GSK Investigational Site

City

Feira de Santana

ZIP/Postal Code

44001-584

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

ZIP/Postal Code

90035-070

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

ZIP/Postal Code

90035-903

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

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

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Montana

ZIP/Postal Code

3400

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

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7002

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

1309

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1709

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

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3M 0B2

Country

Canada

Facility Name

GSK Investigational Site

City

Beroun

ZIP/Postal Code

26601

Country

Czechia

Facility Name

GSK Investigational Site

City

Frýdek-mistek

ZIP/Postal Code

738 18

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

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

14021

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

142 00

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

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

GSK Investigational Site

City

Parnu

ZIP/Postal Code

80011

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

Bois-Guillaume

ZIP/Postal Code

76230

Country

France

Facility Name

GSK Investigational Site

City

Bordeaux

ZIP/Postal Code

33076

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

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

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

GSK Investigational Site

City

Tours cedex 9

ZIP/Postal Code

37044

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

Bad Koenig

State/Province

Hessen

ZIP/Postal Code

64732

Country

Germany

Facility Name

GSK Investigational Site

City

Wiesbaden

State/Province

Hessen

ZIP/Postal Code

65191

Country

Germany

Facility Name

GSK Investigational Site

City

Rostock

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18059

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

Kaiserslautern

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67655

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

GSK Investigational Site

City

Dieburg

ZIP/Postal Code

64807

Country

Germany

Facility Name

GSK Investigational Site

City

Freiburg

ZIP/Postal Code

79110

Country

Germany

Facility Name

GSK Investigational Site

City

Minden

ZIP/Postal Code

32429

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

11527

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

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

56403

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1077

Country

Hungary

Facility Name

GSK Investigational Site

City

Egri

ZIP/Postal Code

3300

Country

Hungary

Facility Name

GSK Investigational Site

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

GSK Investigational Site

City

Kecskemet

ZIP/Postal Code

6001

Country

Hungary

Facility Name

GSK Investigational Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

GSK Investigational Site

City

Pécs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

GSK Investigational Site

City

Pécs

ZIP/Postal Code

7633

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

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

Chennai, Tamil Nadu

ZIP/Postal Code

600 006

Country

India

Facility Name

GSK Investigational Site

City

Chennai

ZIP/Postal Code

600 034

Country

India

Facility Name

GSK Investigational Site

City

Delhi

ZIP/Postal Code

110076

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

500034

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302004

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

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

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

GSK Investigational Site

City

Reggio Calabria

State/Province

Calabria

ZIP/Postal Code

89124

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

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

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

20153

Country

Italy

Facility Name

GSK Investigational Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20900

Country

Italy

Facility Name

GSK Investigational Site

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

GSK Investigational Site

City

Seriate

State/Province

Lombardia

ZIP/Postal Code

24068

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-si,

ZIP/Postal Code

14647

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-si

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Goyang-si, Gyeonggi-do

ZIP/Postal Code

411706

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Goyang-si

ZIP/Postal Code

10475

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Goyang-si

ZIP/Postal Code

410-719

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

463-707

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

Seoul

ZIP/Postal Code

05030

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

07061

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

07441

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

135-720

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-713

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

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

Batu Caves

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

GSK Investigational Site

City

Ipoh

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

GSK Investigational Site

City

Johor Bahru

ZIP/Postal Code

80100

Country

Malaysia

Facility Name

GSK Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

50603

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

Durango.

State/Province

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

GSK Investigational Site

City

Ciudad De México

State/Province

Estado De México

ZIP/Postal Code

14000

Country

Mexico

Facility Name

GSK Investigational Site

City

Cuautitlan Izcalli

State/Province

Estado De México

ZIP/Postal Code

54769

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44620

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

GSK Investigational Site

City

Queretaro

State/Province

Querétaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

GSK Investigational Site

City

Merida

State/Province

Yucatán

ZIP/Postal Code

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

México, D.F.

ZIP/Postal Code

14080

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

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

Oslo

ZIP/Postal Code

0405

Country

Norway

Facility Name

GSK Investigational Site

City

Stavanger

ZIP/Postal Code

4011

Country

Norway

Facility Name

GSK Investigational Site

City

Biala Podlaska

ZIP/Postal Code

21-500

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-462

Country

Poland

Facility Name

GSK Investigational Site

City

Grojec

ZIP/Postal Code

05-600

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

Kolo

ZIP/Postal Code

62-600

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-262

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

92-213

Country

Poland

Facility Name

GSK Investigational Site

City

Olkusz

ZIP/Postal Code

32-300

Country

Poland

Facility Name

GSK Investigational Site

City

Pruszkow

ZIP/Postal Code

05-800

Country

Poland

Facility Name

GSK Investigational Site

City

Tomaszow Mazowiecki

ZIP/Postal Code

97-200

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

GSK Investigational Site

City

Zary

ZIP/Postal Code

68-200

Country

Poland

Facility Name

GSK Investigational Site

City

Amadora

ZIP/Postal Code

2700-391

Country

Portugal

Facility Name

GSK Investigational Site

City

Corroios.

ZIP/Postal Code

2855227

Country

Portugal

Facility Name

GSK Investigational Site

City

Covilhã

ZIP/Postal Code

6200-000

Country

Portugal

Facility Name

GSK Investigational Site

City

Forte Da Casa

ZIP/Postal Code

2625-437

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

1250-203

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1400-195

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1750-130

Country

Portugal

Facility Name

GSK Investigational Site

City

Mirandela

ZIP/Postal Code

5370-530

Country

Portugal

Facility Name

GSK Investigational Site

City

Portimão

ZIP/Postal Code

8500-311

Country

Portugal

Facility Name

GSK Investigational Site

City

Vila Franca de Xira

ZIP/Postal Code

2600-076

Country

Portugal

Facility Name

GSK Investigational Site

City

Vila Real (Lordelo)

ZIP/Postal Code

5000-668

Country

Portugal

Facility Name

GSK Investigational Site

City

Arad

ZIP/Postal Code

310141

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Resita

ZIP/Postal Code

320166

Country

Romania

Facility Name

GSK Investigational Site

City

Targu-Jiu

ZIP/Postal Code

210146

Country

Romania

Facility Name

GSK Investigational Site

City

Irkutsk

ZIP/Postal Code

664049

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnodar

ZIP/Postal Code

350029

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Mytischi

ZIP/Postal Code

141009

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Omsk

ZIP/Postal Code

644112

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Orenburg

ZIP/Postal Code

460040

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Penza

ZIP/Postal Code

440034

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196247

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

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

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Alcala de Henares

ZIP/Postal Code

28805

Country

Spain

Facility Name

GSK Investigational Site

City

Aranda de Duero

ZIP/Postal Code

09400

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08036

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

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Ciudad Real

ZIP/Postal Code

13005

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

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28020

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Manises (Valencia)

ZIP/Postal Code

46940

Country

Spain

Facility Name

GSK Investigational Site

City

Mollet del Valles

ZIP/Postal Code

08100

Country

Spain

Facility Name

GSK Investigational Site

City

Málaga

ZIP/Postal Code

29530

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07120

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell

ZIP/Postal Code

08208

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

Valladolid

ZIP/Postal Code

47005

Country

Spain

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-141 86

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-182 88

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

756 55

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

83301

Country

Taiwan

Facility Name

GSK Investigational Site

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Facility Name

GSK Investigational Site

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

GSK Investigational Site

City

New Taipei City

ZIP/Postal Code

237

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

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

Zhongzheng Dist., Taipei

ZIP/Postal Code

10002

Country

Taiwan

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

Kayseri

ZIP/Postal Code

38039

Country

Turkey

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

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

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

Mykolaiv

ZIP/Postal Code

54058

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

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

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

Dundee

ZIP/Postal Code

DD1 9SY

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

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

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

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

PubMed Identifier

34739194

Citation

Singh AK, Carroll K, Perkovic V, 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, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.

Results Reference

derived

PubMed Identifier

33744933

Citation

Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.

Results Reference

derived

Learn more about this trial

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

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

Anaemia, Aspergillosis, Allergic Bronchopulmonary

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