Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
This trial is active, not recruiting.
|Conditions||chronic kidney disease, end-stage renal failure, anaemia|
|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|
|Kuantan, Malaysia||Pusat Hemodialisis Islam Makmur||no longer recruiting|
|Kuantan, Malaysia||Pahang Buddhist Association||no longer recruiting|
|Klang, Malaysia||SP Menon Dialysis Centre||no longer recruiting|
|Petaling Jaya, Malaysia||Tan Medical Renal Clinic||no longer recruiting|
|PJ, Malaysia||SP Menon Dialysis Centre||no longer recruiting|
|Subang Jaya, Malaysia||Sunway Medical Centre||no longer recruiting|
|Subang Jaya, Malaysia||Klinik Pakar Dialysis||no longer recruiting|
|KL, Malaysia||The Kidney Dialysis Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||The Kidney Dialysis Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||Gleneagles Intan Medical Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||Cheras Dialysis Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||Aiman Dialysis Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||Ampang Putri Specialist Hospital||no longer recruiting|
|Kuala Lumpur, Malaysia||Pantai Medical Centre||no longer recruiting|
|Kuala Lumpur, Malaysia||Smartcare Dialysis Centre||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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.
Mortality, quality of life and cost during the 6 years study treatment.
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.
|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.|
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