NCT02708914

Study to Compare the Safety and Efficacy of UB-851 and Eprex®

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: UBI Pharma Inc. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
BIOLOGICAL	UB-851	UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.
BIOLOGICAL	Eprex	Eprex® is chosen as the comparator.

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2016-03-15
• Last updated: 2023-12-06