Efficacy and Safety Study of GerEPO

October 25, 2006 updated by: Ministry of Health, Malaysia

A Randomized, Multi-Center, Open Label Trial to Establish the Therapeutic Equivalence Between GerEpo and Eprex® and to Determine the Long Term Safety Profile of GerEpo in Patients on Hemodialysis.

The purpose of the study is to establish the equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response and to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

270 patients on Hemodialysis from 25 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. At the end of the comparative trial, subjects on either arm of the study may opt to enter a longer term cohort study designed to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event.

This second part of the study is also opened to all subjects who have given written informed consent, and have ESRF with CRF related anemia who according to current guideline should be treated with Epoetin. Subjects need not be included in the first part of the study.

All patients shall be treated with GerEpo and thereafter observed for at least 1 year to actively monitor for the occurrence of PRCA and other immunogenicity related adverse events. The cohort study shall continue until at least 10,000 patient-years of observation have accrued on the study database.

Study Type

Interventional

Enrollment

270

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
      • Melaka, Malaysia, 75400
        • Hospital Melaka
      • Pulau Pinang, Malaysia, 10990
        • Penang General Hospital
    • Johor
      • Johor Bharu, Johor, Malaysia, 80100
        • Hospital Sultanah Aminah
      • Pontian, Johor, Malaysia, 82000
        • Pontian Rotary Haemodialysis Centre
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05100
        • Hospital Alor Setar
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15590
        • Hospital Kota Bharu
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Pusat Hemodialisis Mawar (Seremban)
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Seremban General Hospital
    • Pahang
      • Kuantan, Pahang, Malaysia
        • Pahang Buddhist Association
      • Kuantan, Pahang, Malaysia
        • Hospital Tengku Ampuan Afzan
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Hospital Ipoh
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping
    • Perlis
      • Kangar, Perlis, Malaysia, 01000
        • Hospital Kangar
    • Pulau Pinang
      • Bukit Mertajam, Pulau Pinang, Malaysia, 14000
        • Asia Renal Care,Bukit Mertajam
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88586
        • Hospital Queen Elizabeth
      • Kota Kinabalu, Sabah, Malaysia, 88100
        • Persatuan Buah Pinggang Sabah
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Hospital Umum Sarawak
      • Kuching, Sarawak, Malaysia, 93250
        • Timberland Medical Centre
      • Kuching, Sarawak, Malaysia, 93540
        • MAA Medicare Kidney Charity Dialysis Centre
    • Selangor
      • Ampang, Selangor, Malaysia
        • Ampang Putri Specialist Hospital
      • Batu Caves, Selangor, Malaysia
        • Hospital Selayang
      • Klang, Selangor, Malaysia, 41200
        • Hospital Tengku Ampuan Rahimah
      • Klang, Selangor, Malaysia
        • SP Menon Dialysis Centre
      • PJ, Selangor, Malaysia
        • SP Menon Dialysis Centre, Megah Medical Specialist Centre
      • Petaling Jaya, Selangor, Malaysia, 46150
        • Haemodialysis Unit , Sunway Medical Centre
    • Terengganu
      • Kuala Terengganu, Terengganu, Malaysia, 20400
        • Hospital Kuala Terengganu
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50400
        • SP Menon Dialysis Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 54000
        • Pusat Hemodialisis, Yayasan Felda
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 58100
        • The Kidney Dialysis Centre
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • Pantai Medical Centre, Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia
        • Tung Shin Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent obtained.
  2. Patients age between 18 and 70 years.
  3. Patients who are medically stable on hemodialysis for a minimum of 3 months.
  4. Patients on Eprex® treatment for CRF related anemia and maintaining Hb level at or above 9 g/dL(90g/L) while on a stable dose (no change in dose) of Epoetin within 6 weeks preceding the screening phase of this study.
  5. Patients who have a serum ferritin level greater than 100μg/L and/or transferrin saturation at least 20% within 3 months preceding the screening phase of this study.

Exclusion Criteria:

  1. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, IUD or diaphragms in conjunction with spermicidal foam and condom on the male partner.
  2. Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study.
  3. Those persons directly involved in the conduct of the study.
  4. Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation.
  5. History of seizure disorder.
  6. Active acute or chronic infection or inflammatory disease.
  7. Any illness that had required hospitalization within the last one month.
  8. Had blood transfusion within the last three months.
  9. Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (>500,000/mm3))
  10. Severe hyperparathyroidism
  11. Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To establish the therapeutic equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response.

Secondary Outcome Measures

Outcome Measure
• To compare GerEpo with Eprex® with respect to their respective frequency of adverse events
To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.

Collaborators and Investigators

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

Sponsor

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Zaki Morad, MRCP, FRCP, Ministry of Health

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.

General Publications

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

April 1, 2005

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2006

Last Update Submitted That Met QC Criteria

October 25, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT05-02

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.

Clinical Trials on Chronic Renal Failure Related Anemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe