Status:
COMPLETED
Efficacy and Safety Study of GerEPO
Lead Sponsor:
Ministry of Health, Malaysia
Conditions:
Chronic Renal Failure Related Anemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00229099
Start Date
April 1 2005
End Date
November 1 2005
Last Update
October 26 2006
Active Locations (32)
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1
Hospital Sultanah Aminah
Johor Bharu, Johor, Malaysia, 80100
2
Pontian Rotary Haemodialysis Centre
Pontian Besar, Johor, Malaysia, 82000
3
Hospital Alor Setar
Alor Star, Kedah, Malaysia, 05100
4
Hospital Kota Bharu
Kota Bharu, Kelantan, Malaysia, 15590