4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
Status:
Completed
Trial end date:
2013-05-27
Target enrollment:
Participant gender:
Summary
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center
study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable
rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia
associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a
4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study
eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with
total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening
visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and
Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic
kidney disease after switching from a stable maintenance dose of recombinant human
erythropoetin (rhEPO).