Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
Status:
Completed
Trial end date:
2018-10-26
Target enrollment:
Participant gender:
Summary
This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to
compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta
pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will
consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects
(Erythropoiesis-Stimulating Agent [ESA] users and ESA non-users) randomized to receive
GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort
2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week
treatment phase (including primary efficacy evaluation period [Weeks 40 to 52]), and a 4-week
follow-up phase following the treatment phase. The primary objective of this study is to
demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin
(Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort
1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal
study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.