drugset / Trial / NCT03521713

To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)

NCT03521713

Phase 3 Unknown 214 enrolled Dong-A ST Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.

Timeline

Start
2016-03-01
Primary completion
2020-09
Completion
2021-03

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 50 iu/kg Subcutaneous