Efficacy and Safety Study of GerEPO

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Malaysia

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.