drugset / Trial / NCT02708914

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

NCT02708914

Phase 3 Completed 269 enrolled UBI Pharma Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-03
Primary completion
2021-10
Completion
2021-10

Drugs

EvaluationDrugModalityDoseRoute
Subject UB-851 Protein / enzyme biologic Intravenous
Subject epoetin alfa Protein / enzyme biologic Intravenous

Indications