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4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

Primary Purpose

Anaemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GSK1278863

Placebo

About this trial

This is an interventional treatment trial for Anaemia focused on measuring Anemia, Prolyl hydroxylase inhibitor, Hemoglobin, Chronic kidney disease, pharmacokinetics, recombinant human erythropoietin, GSK1278863

Eligibility Criteria

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

Inclusion Criteria:

Age and weight: >/= 18 years of age and >/= 45 kg.
Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or peritoneal dialysis) or dialysis planned during the time the subject would be enrolled in the study.
No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta), peginesatide or their biosimilars..
KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal Disease (MDRD).
Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
TSAT within the reference range.
Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if required, that will be maintained throughout the study. NOTE: IV iron replacement therapy is not allowed the two weeks prior to Screening through the end of the study (Week 6).
QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at Screening Visit, based on Central Reader's interpretation.
Females: Eligible to participate if she is of childbearing potential, and must agree to use approved contraception methods from Screening until completion of the Follow-up Visit OR of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory]. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most types of HRT, at least 2 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Males: Must agree to use approved contraceptive methods from the time of Screening until completion of the Follow-up Visit.

Exclusion Criteria:

Dialysis: Planning to initiate dialysis during the study or who have a high potential for initiating dialysis during study participation.
Renal transplant: Renal transplant anticipated or scheduled within the study time period or subjects with a functioning renal transplant.
Total CPK: >5x the upper limit of the reference range.
HIV: Positive HIV antibody.
History of myocardial infarction or acute coronary syndrome within the prior 6 months.
History of stroke or TIAs.
Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), or other thrombosis related condition) within the prior 6 months.
Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases).
Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease).
Hematological disease: Any hematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) or any other cause of anemia other than renal disease.
Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
Major surgery: Within the prior 12 weeks or planned during the study.
Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study.
Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer disease or active GI bleeding within the prior 12 weeks.
Acute infection: Clinical evidence of acute infection or history of infection requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening through Day 1 (randomization).
Malignancy: History of malignancy within 5 years of Screening or are receiving treatment for cancer or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the Investigator, including subjects with parathyroid hormone (PTH) values ≥600 pg/mL.
Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months, or macular edema requiring treatment.
Severe reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening until the Follow-up Visit.
Androgens: New androgen therapy or changes to pre-existing androgen regimen within prior 12 weeks.
Prior investigational product exposure: The subject has participated in a clinical trial and has received an experimental investigational product within prior 30 days.
Protocol compliance: Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol.
Other conditions: Any condition which in the investigators opinion should exclude the subject from participating in the study.
Pregnancy and lactation: Pregnant females as determined by positive urine hCG test, OR women who are lactating at Screening or during the trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

0.5mg GSK1278863

2mg GSK1278863

5mg GSK1278863

Placebo

Arm Description

Once daily

Outcomes

Primary Outcome Measures

Modeled Hgb Change From Baseline Over 4 Weeks of Treatment

Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Secondary Outcome Measures

Model-Adjusted Maximum Hgb Changes Over 4 Weeks

Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values.

Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb

Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.

Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb

Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.

Number of Participants Who Reached Hgb Stopping Criteria

The Hgb stopping criteria was defined as reaching to value <8.0 g/dL, >=8.0 - <13.0 (>= 2g/dL absolute Hgb change over 1 week ) or >=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented.

Change From Baseline in Hepcidin at Week 2 and Week 4

Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed.

Change From Baseline in Ferritin at Week 2 and Week 4

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Transferrin at Week 2 and Week 4

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Transferrin Saturation at Week 2 and Week 4

Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4

Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Total Iron at Week 2 and Week 4

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Erythropoietin at Week 2 and Week 4

Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Red Blood Cells Count Over 4 Weeks

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4

Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Number of Participants Discontinuing the Study Treatment Due to AEs

Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6

Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6

Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6

Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6

Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6

Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.

Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6

Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6

Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported.

Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported.

Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.

Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.

Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6

Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6

Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.

Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.

Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.

Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6

Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).

Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6

Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported.

Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).

Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6

Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported.

Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6

Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported.

Change From Baseline in ECG Parameters at Week 2, 4 and 6

Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.

Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites

Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).

Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites

Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).

Full Information

NCT ID

NCT01587898

First Posted

April 19, 2012

Last Updated

October 9, 2017

Sponsor

GlaxoSmithKline

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT01587898

Brief Title

4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

Official Title

A Four-week Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Recombinant Human Erythropoietin and Are Not Undergoing Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

May 17, 2012 (Actual)

Primary Completion Date

May 7, 2013 (Actual)

Study Completion Date

May 7, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

PPD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The study consists of a screening phase of up to 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion. Study treatment will be stopped if Hgb values fall outside of the range pre-specified in the protocol. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response for correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO (NDD). In addition, the study will characterize the effect of GSK1278863 on various pharmacokinetic/pharmacodynamic (PK/PD) markers, and will investigate the safety and tolerability of GSK1278863. An early interim analysis of the Hgb data is planned after approximately 20 subjects from cohort 1 have completed 3 weeks of treatment. Depending upon the interim findings, a second cohort of subjects may be added to investigate an additional GSK1278863 dose arm. Recruitment to the first cohort will continue during the interim analysis. A second interim analysis is planned after approximately 48 subjects from cohort 1 have completed 4 weeks treatment. The purpose of this interim is three-fold, to investigate whether a second cohort of subjects may be added, to facilitate early development of dose-response and PK/PD statistical models, and to generate interim results to facilitate design and dosing decisions for the next trial. Subject completion is defined as completion of all study phases including the follow-up phase.

6. Conditions and Keywords

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

Anaemia

Keywords

Anemia, Prolyl hydroxylase inhibitor, Hemoglobin, Chronic kidney disease, pharmacokinetics, recombinant human erythropoietin, GSK1278863

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5mg GSK1278863

Arm Type

Experimental

Arm Description

Once daily

Arm Title

2mg GSK1278863

Arm Type

Experimental

Arm Description

Once daily

Arm Title

5mg GSK1278863

Arm Type

Experimental

Arm Description

Once daily

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Once daily

Intervention Type

Drug

Intervention Name(s)

GSK1278863

Intervention Description

Tablet

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

Modeled Hgb Change From Baseline Over 4 Weeks of Treatment

Description

Time Frame

Baseline (average of Week -2, -1 and Day 1) and Week 4

Secondary Outcome Measure Information:

Title

Model-Adjusted Maximum Hgb Changes Over 4 Weeks

Description

Time Frame

Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks

Title

Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb

Description

Time Frame

Up to 4 weeks

Title

Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb

Description

Time Frame

Up to 4 weeks

Title

Number of Participants Who Reached Hgb Stopping Criteria

Description

Time Frame

Up to Week 4

Title

Change From Baseline in Hepcidin at Week 2 and Week 4

Description

Time Frame

Baseline (Pre-dose on Day 1), Week 2 and 4

Title

Change From Baseline in Ferritin at Week 2 and Week 4

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Transferrin at Week 2 and Week 4

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Transferrin Saturation at Week 2 and Week 4

Description

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4

Description

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Total Iron at Week 2 and Week 4

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4

Title

Change From Baseline in Erythropoietin at Week 2 and Week 4

Description

Time Frame

Baseline (Day 1 Pre-dose), Week 2 and 4

Title

Change From Baseline in Red Blood Cells Count Over 4 Weeks

Description

Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.

Time Frame

Baseline (Day 1 pre-dose), week 1, 2, 3, 4

Title

Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4

Description

Time Frame

Baseline (Pre-dose), week 2 and 4

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Up to 6 weeks

Title

Number of Participants Discontinuing the Study Treatment Due to AEs

Description

Time Frame

Up to 6 weeks

Title

Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6

Description

Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 2, 4, and 6

Title

Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6

Description

Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 2, 4, and 6

Title

Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 2, 4, and 6

Title

Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6

Description

Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 2, 4, and 6

Title

Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6

Description

Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6

Description

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6

Description

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6

Description

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6

Description

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6

Description

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.

Time Frame

Baseline (Day 1), Week 2, 4, and 6

Title

Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6

Description

Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Description

Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Description

Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6

Description

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.

Time Frame

Baseline (Day 1), Week 1, 2, 3, 4, and 6

Title

Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6

Description

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.

Time Frame

Baseline (Day 1), Week 1, 2, 3, 4, and 6

Title

Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6

Description

Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.

Time Frame

Baseline (Day 1), Week 1, 2, 3, 4, and 6

Title

Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6

Description

Time Frame

Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6

Title

Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6

Description

Time Frame

Baseline (Screening), Week 2, 4, and 6

Title

Change From Baseline in ECG Parameters at Week 2, 4 and 6

Description

Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.

Time Frame

Baseline (Screening), Week 2, 4, and 6

Title

Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites

Description

Time Frame

Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).

Title

Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites

Description

Time Frame

Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)

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 and weight: >/= 18 years of age and >/= 45 kg. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or peritoneal dialysis) or dialysis planned during the time the subject would be enrolled in the study. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta), peginesatide or their biosimilars.. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal Disease (MDRD). Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months). Folate: >/=2.0 ng/mL at Screening. May rescreen in a month. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs. TSAT within the reference range. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if required, that will be maintained throughout the study. NOTE: IV iron replacement therapy is not allowed the two weeks prior to Screening through the end of the study (Week 6). QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at Screening Visit, based on Central Reader's interpretation. Females: Eligible to participate if she is of childbearing potential, and must agree to use approved contraception methods from Screening until completion of the Follow-up Visit OR of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory]. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most types of HRT, at least 2 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Males: Must agree to use approved contraceptive methods from the time of Screening until completion of the Follow-up Visit. Exclusion Criteria: Dialysis: Planning to initiate dialysis during the study or who have a high potential for initiating dialysis during study participation. Renal transplant: Renal transplant anticipated or scheduled within the study time period or subjects with a functioning renal transplant. Total CPK: >5x the upper limit of the reference range. HIV: Positive HIV antibody. History of myocardial infarction or acute coronary syndrome within the prior 6 months. History of stroke or TIAs. Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), or other thrombosis related condition) within the prior 6 months. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases). Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease). Hematological disease: Any hematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) or any other cause of anemia other than renal disease. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study. Major surgery: Within the prior 12 weeks or planned during the study. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer disease or active GI bleeding within the prior 12 weeks. Acute infection: Clinical evidence of acute infection or history of infection requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening through Day 1 (randomization). Malignancy: History of malignancy within 5 years of Screening or are receiving treatment for cancer or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the Investigator, including subjects with parathyroid hormone (PTH) values ≥600 pg/mL. Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months, or macular edema requiring treatment. Severe reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening until the Follow-up Visit. Androgens: New androgen therapy or changes to pre-existing androgen regimen within prior 12 weeks. Prior investigational product exposure: The subject has participated in a clinical trial and has received an experimental investigational product within prior 30 days. Protocol compliance: Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol. Other conditions: Any condition which in the investigators opinion should exclude the subject from participating in the study. Pregnancy and lactation: Pregnant females as determined by positive urine hCG test, OR women who are lactating at Screening or during the trial.

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

Azusa

State/Province

California

ZIP/Postal Code

91702

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

Chino

State/Province

California

ZIP/Postal Code

91710

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

90025

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

GSK Investigational Site

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606-1559

Country

United States

Facility Name

GSK Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

GSK Investigational Site

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Facility Name

GSK Investigational Site

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

GSK Investigational Site

City

Yuba City

State/Province

California

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

GSK Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32258

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33150

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

GSK Investigational Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

GSK Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

GSK Investigational Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

GSK Investigational Site

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

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

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

GSK Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

GSK Investigational Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16507

Country

United States

Facility Name

GSK Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

GSK Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78751

Country

United States

Facility Name

GSK Investigational Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

Texas

ZIP/Postal Code

75402

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76502

Country

United States

Facility Name

GSK Investigational Site

City

Silverdale

State/Province

Washington

ZIP/Postal Code

98383

Country

United States

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2R 0X7

Country

Canada

Facility Name

GSK Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Aschaffenburg

State/Province

Bayern

ZIP/Postal Code

63741

Country

Germany

Facility Name

GSK Investigational Site

City

Demmin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

17109

Country

Germany

Facility Name

GSK Investigational Site

City

Lehrte

State/Province

Niedersachsen

ZIP/Postal Code

31275

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22297

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

26494831

Citation

Holdstock L, Meadowcroft AM, Maier R, Johnson BM, Jones D, Rastogi A, Zeig S, Lepore JJ, Cobitz AR. Four-Week Studies of Oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor GSK1278863 for Treatment of Anemia. J Am Soc Nephrol. 2016 Apr;27(4):1234-44. doi: 10.1681/ASN.2014111139. Epub 2015 Oct 22.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116581

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

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4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

Anaemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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