Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
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.
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.