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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02708914
Study type Interventional
Source UBI Pharma Inc.
Contact
Status Completed
Phase Phase 3
Start date March 2016
Completion date October 2021

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