Efficacy and Safety Study of GerEPO

This study has been completed.
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT00229099
First received: September 28, 2005
Last updated: October 25, 2006
Last verified: December 2005
  Purpose

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


Condition Intervention Phase
Chronic Renal Failure Related Anemia
Drug: GerEPO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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:
  • • 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.

Estimated Enrollment: 270
Study Start Date: April 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229099

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

Additional Information:
No publications provided by Ministry of Health, Malaysia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00229099     History of Changes
Other Study ID Numbers: CT05-02
Study First Received: September 28, 2005
Last Updated: October 25, 2006
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014