This trial is active, not recruiting.

Conditions chronic kidney disease, end-stage renal failure, anaemia
Treatment biogeneric epoetin
Phase phase 3
Sponsor Ministry of Health, Malaysia
Start date August 2005
End date April 2011
Trial size 2000 participants
Trial identifier NCT00238043, CT 05-17


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 on long-term health outcome and its cost effectiveness.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

To investigate the Hb levels at each every 3 months follow up visit and the incidence of lack anticipated Hb response or loss of response to Biogeneric Epoetin. To monitor the occurrence of PRCA and other immunogenicity related adverse event.
time frame:

Secondary Outcomes

Mortality, quality of life and cost during the 6 years study treatment.
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Principal investigator Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP
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 and to determine the long term safety profile of Biogeneric Epoetin in patients on Hemodialysis". In the first stage, a biogeneric Epoetin shall be evaluated by a randomized trial designed to demonstrate therapeutic equivalence (TE) versus an innovator product (Eprex), the efficacy clinical end-point being Hb at 6 to 12 weeks on treatment. When preliminary evidence of efficacy is established from above stage 1 TE trial, the product may proceed to be evaluated in a stage 2 single group cohort study designed to establish the long term safety, with particular emphasis on surveillance for occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event. To establish the long term efficacy, its emphasis on the potential impact of batch to batch variation in product content and potency (bioactivity) on Hb response. This practical trial also designed to investigate the cost-effectiveness by estimating the optimal dosage for combination of Epoetin and Iron sucrose to achieve Hb target under unconstrained prescriptionas, and hence the budgetary requirement can be estimated to meet therapeutic target in this dialysis population under various pricing scenario in the presence of generic competition.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Ministry of Health, Malaysia.