Conditions: Anaemia
Keywords: Hemodialysis GSK1278863 Pharmacokinetics Erythropoiesis Stimulating Agents Chronic Kidney Disease Hemoglobin Recombinant Erythropoietin Prolyl Hydroxylase Inhibitor Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: no

Brief summary:
This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.

Detailed description:

Arms:
arm 1: Subjects will receive GSK1278863 4 mg once daily for 4 weeks arm 2: Subjects will receive GSK1278863 6 mg once daily for 4 weeks arm 3: Subjects will receive GSK1278863 8 mg once daily for 4 weeks arm 4: Subjects will receive GSK1278863 10 mg once daily for 4 weeks arm 5: Subjects will receive placebo once daily for 4 weeks

Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1278863 will be supplied as film coated tablets for oral administration containing 1 mg, 2 mg, or 5 mg of GSK1278863. intervention 2: Film coated tablets of GSK1278863 matching placebo for oral administration.

Protocol document: