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

June 12, 2008 updated by: Ministry of Health, Malaysia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Pahang
      • Kuantan, Pahang, Malaysia
        • Pahang Buddhist Association
      • Kuantan, Pahang, Malaysia
        • Pusat Hemodialisis Islam Makmur
    • Selangor
      • Klang, Selangor, Malaysia
        • SP Menon Dialysis Centre
      • PJ, Selangor, Malaysia
        • SP Menon Dialysis Centre
      • Petaling Jaya, Selangor, Malaysia
        • Tan Medical Renal Clinic
      • Subang Jaya, Selangor, Malaysia
        • Klinik Pakar Dialysis
      • Subang Jaya, Selangor, Malaysia
        • Sunway Medical Centre
    • Wilayah Persekutuan
      • KL, Wilayah Persekutuan, 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
        • Cheras Dialysis Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • Gleneagles Intan Medical Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • Pantai Medical Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • Smartcare Dialysis Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • The Kidney Dialysis Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Mortality, quality of life and cost during the 6 years study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP, Department of Nephrology, Kuala Lumpur Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (ANTICIPATED)

April 1, 2011

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (ESTIMATE)

October 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 12, 2008

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 05-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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