Chronic Kidney Disease Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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