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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-04-30

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

Keywords

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Biogeneric Epoetin treatment Renal anaemia Chronic Kidney Disease Pure Red Blood Cell Aplasia Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Biogeneric Epoetin

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Kuala Lumpur Hospital

Locations

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