Status:
UNKNOWN
Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
Lead Sponsor:
Ministry of Health, Malaysia
Conditions:
Chronic Kidney Disease
End-Stage Renal Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to establish the long-term safety and efficacy of Biogeneric Epoetin, the attainability of therapeutic target for anaemia management, and the impact of Epoetin treatment o...
Detailed Description
This study protocol is an elaboration of the original study protocol titled "A Randomized, Multi-center, Open label trial to establish the therapeutic equivalence between Biogeneric Epoetin and Eprex ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient who has Chronic Kidney Disease with anaemia for which Epoetin treatment is indicated.
- Patient without known hypersensitivity to the mammalian cell-derived product or human albumin products.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00238043
Start Date
August 1 2005
End Date
April 1 2011
Last Update
June 17 2008
Active Locations (14)
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1
Aiman Dialysis Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
2
Ampang Putri Specialist Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
3
Cheras Dialysis Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
4
Gleneagles Intan Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia