Study to Compare the Safety and Efficacy of UB-851 and Eprex®
brief summary
The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.
detailed description
This is a 52-week, phase III trial consisting of two parts:
Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks.
Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.
official title
A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis