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Efficacy and Safety Study of GerEPO

Primary Purpose

Chronic Renal Failure Related Anemia

Status
Completed
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
GerEPO
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure Related Anemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent obtained. Patients age between 18 and 70 years. Patients who are medically stable on hemodialysis for a minimum of 3 months. 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. 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: 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. Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study. Those persons directly involved in the conduct of the study. Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation. History of seizure disorder. Active acute or chronic infection or inflammatory disease. Any illness that had required hospitalization within the last one month. Had blood transfusion within the last three months. Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (>500,000/mm3)) Severe hyperparathyroidism Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.

Sites / Locations

  • Hospital Sultanah Aminah
  • Pontian Rotary Haemodialysis Centre
  • Hospital Alor Setar
  • Hospital Kota Bharu
  • Pusat Hemodialisis Mawar (Seremban)
  • Seremban General Hospital
  • Hospital Tengku Ampuan Afzan
  • Pahang Buddhist Association
  • Hospital Ipoh
  • Hospital Taiping
  • Hospital Kangar
  • Asia Renal Care,Bukit Mertajam
  • Persatuan Buah Pinggang Sabah
  • Hospital Queen Elizabeth
  • Timberland Medical Centre
  • MAA Medicare Kidney Charity Dialysis Centre
  • Hospital Umum Sarawak
  • Ampang Putri Specialist Hospital
  • Hospital Selayang
  • Hospital Tengku Ampuan Rahimah
  • SP Menon Dialysis Centre
  • Haemodialysis Unit , Sunway Medical Centre
  • SP Menon Dialysis Centre, Megah Medical Specialist Centre
  • Hospital Kuala Terengganu
  • SP Menon Dialysis Centre
  • Pusat Hemodialisis, Yayasan Felda
  • The Kidney Dialysis Centre
  • Pantai Medical Centre, Kuala Lumpur
  • Hospital Kuala Lumpur
  • Tung Shin Hospital
  • Hospital Melaka
  • Penang General Hospital

Outcomes

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.

Full Information

First Posted
September 28, 2005
Last Updated
October 25, 2006
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT00229099
Brief Title
Efficacy and Safety Study of GerEPO
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure Related Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GerEPO
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• To compare GerEpo with Eprex® with respect to their respective frequency of adverse events
Title
To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained. Patients age between 18 and 70 years. Patients who are medically stable on hemodialysis for a minimum of 3 months. 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. 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: 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. Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study. Those persons directly involved in the conduct of the study. Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation. History of seizure disorder. Active acute or chronic infection or inflammatory disease. Any illness that had required hospitalization within the last one month. Had blood transfusion within the last three months. Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (>500,000/mm3)) Severe hyperparathyroidism Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaki Morad, MRCP, FRCP
Organizational Affiliation
Ministry of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sultanah Aminah
City
Johor Bharu
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Pontian Rotary Haemodialysis Centre
City
Pontian
State/Province
Johor
ZIP/Postal Code
82000
Country
Malaysia
Facility Name
Hospital Alor Setar
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05100
Country
Malaysia
Facility Name
Hospital Kota Bharu
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15590
Country
Malaysia
Facility Name
Pusat Hemodialisis Mawar (Seremban)
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Seremban General Hospital
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
State/Province
Pahang
Country
Malaysia
Facility Name
Pahang Buddhist Association
City
Kuantan
State/Province
Pahang
Country
Malaysia
Facility Name
Hospital Ipoh
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Hospital Kangar
City
Kangar
State/Province
Perlis
ZIP/Postal Code
01000
Country
Malaysia
Facility Name
Asia Renal Care,Bukit Mertajam
City
Bukit Mertajam
State/Province
Pulau Pinang
ZIP/Postal Code
14000
Country
Malaysia
Facility Name
Persatuan Buah Pinggang Sabah
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88100
Country
Malaysia
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Facility Name
Timberland Medical Centre
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93250
Country
Malaysia
Facility Name
MAA Medicare Kidney Charity Dialysis Centre
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93540
Country
Malaysia
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Ampang Putri Specialist Hospital
City
Ampang
State/Province
Selangor
Country
Malaysia
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Rahimah
City
Klang
State/Province
Selangor
ZIP/Postal Code
41200
Country
Malaysia
Facility Name
SP Menon Dialysis Centre
City
Klang
State/Province
Selangor
Country
Malaysia
Facility Name
Haemodialysis Unit , Sunway Medical Centre
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
SP Menon Dialysis Centre, Megah Medical Specialist Centre
City
PJ
State/Province
Selangor
Country
Malaysia
Facility Name
Hospital Kuala Terengganu
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
SP Menon Dialysis Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Pusat Hemodialisis, Yayasan Felda
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
54000
Country
Malaysia
Facility Name
The Kidney Dialysis Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
58100
Country
Malaysia
Facility Name
Pantai Medical Centre, Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
Country
Malaysia
Facility Name
Tung Shin Hospital
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
Country
Malaysia
Facility Name
Hospital Melaka
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Facility Name
Penang General Hospital
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
17803464
Citation
Goh BL, Ong LM, Sivanandam S, Lim TO, Morad Z; Biogeneric EPO Study Group. Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis. Nephrology (Carlton). 2007 Oct;12(5):431-6. doi: 10.1111/j.1440-1797.2007.00831.x.
Results Reference
derived
Links:
URL
http://www.crc.gov.my
Description
the link is an academic research organisation for the trial

Learn more about this trial

Efficacy and Safety Study of GerEPO

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