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Efficacy and Safety Study of GerEPO

NCT00229099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2006-10-26

No results posted yet for this study

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

Conditions

  • Chronic Renal Failure Related Anemia

Interventions

DRUG

GerEPO

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Zaki Morad, MRCP, FRCP · Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2005-11-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00229099 on ClinicalTrials.gov