Overview

Efficacy and Safety Study of GerEPO

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to establish the equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response and to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event
Phase:
Phase 3
Details
Lead Sponsor:
Ministry of Health, Malaysia