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

Phase 3

• Conditions: Chronic Kidney Disease; End-Stage Renal Failure; Anaemia

• Registration Number: NCT00238043
• Lead Sponsor: Ministry of Health, Malaysia

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-08
• Status Verified: 2005-10
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Last Update Submitted: 2008-06-12
• Last Update Posted: 2008-06-17
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortality, quality of life and cost during the 6 years study treatment.

Trial Locations

Locations (13)

Pusat Hemodialisis Islam Makmur; 🇲🇾 Kuantan, Pahang, Malaysia

SP Menon Dialysis Centre; 🇲🇾 PJ, Selangor, Malaysia

Pahang Buddhist Association; 🇲🇾 Kuantan, Pahang, Malaysia

Gleneagles Intan Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Sunway Medical Centre; 🇲🇾 Subang Jaya, Selangor, Malaysia

The Kidney Dialysis Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Aiman Dialysis Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Ampang Putri Specialist Hospital; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Smartcare Dialysis Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Pantai Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Cheras Dialysis Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia

Klinik Pakar Dialysis; 🇲🇾 Subang Jaya, Selangor, Malaysia

Tan Medical Renal Clinic; 🇲🇾 Petaling Jaya, Selangor, Malaysia