JR-131, a biosimilar of darbepoetin alfa, for the treatment of hemodialysis patients with renal anemia: a randomized, double-blinded, parallel-group phase 3 study
Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Kobe, Japan. Data Science Division, Kissei Pharmaceutical Co., Ltd., Tokyo, Japan. Department of Nephrology, Nara Medical University, Nara, Japan. Honcho Yabuki Clinic, Yamagata, Japan. Department of General Internal Medicine, Saitama Medical University, Saitama, Japan.
Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy. 2019
The aim of this study was to compare the efficacy and safety of intravenous JR-131, a darbepoetin alfa biosimilar, to darbepoetin alfa in hemodialysis patients with renal anemia. In this 24-week, multicenter, randomized, double-blinded, parallel-group phase 3 study, 334 hemodialysis patients with renal anemia who had been receiving darbepoetin alfa were randomized to either JR-131 or darbepoetin alfa group. The
initial dose was set based on the darbepoetin alfa dose during the observation period. The primary endpoint was change in hemoglobin level from baseline to end of treatment. The 95% confidence interval of the difference in the change in hemoglobin level between the groups was -0.19 g/dL to -0.20 g/dL, within the equivalent margin of -0.5 g/dL to 0.5 g/dL. No notable adverse events were observed in either group. JR-131 was therapeutically equivalent to darbepoetin alfa, and the safety profile of JR-131 was similar to that of darbepoetin alfa. This article is protected by copyright. All rights reserved.
