Last updated on January 2017

Phase III Study of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Renal Anemia

Brief description of study

This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy (verification of noninferiority) and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 270 Japanese non-dialysis (ND) and 50 peritoneal dialysis (PD) subjects with renal anemia. The study will consist of 2 cohorts of different subject populations. This study consists of a 4-week screening phase, a 52-week treatment phase (including the 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 hemoglobin (Hgb) in the ND subject population included in this study. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.

Clinical Study Identifier: NCT02791763

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