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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Chronic Kidney Disease, End-Stage Renal Failure, Anaemia

Intervention / Treatment
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* Drug: Biogeneric Epoetin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Biogeneric Epoetin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, quality of life and cost during the 6 years study treatment. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biogeneric Epoetin treatment, Renal anaemia, Chronic Kidney Disease, Pure Red Blood Cell Aplasia, Hemodialysis