Chronic Renal Failure Related Anemia Clinical Trial
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.
| Verified date | December 2005 |
| Source | Ministry of Health, Malaysia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Malaysia: Ministry of Health |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | November 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Hospital Alor Setar | Alor Setar | Kedah |
| Malaysia | Ampang Putri Specialist Hospital | Ampang | Selangor |
| Malaysia | Hospital Selayang | Batu Caves | Selangor |
| Malaysia | Asia Renal Care,Bukit Mertajam | Bukit Mertajam | Pulau Pinang |
| Malaysia | Hospital Ipoh | Ipoh | Perak |
| Malaysia | Hospital Sultanah Aminah | Johor Bharu | Johor |
| Malaysia | Hospital Kangar | Kangar | Perlis |
| Malaysia | Hospital Tengku Ampuan Rahimah | Klang | Selangor |
| Malaysia | SP Menon Dialysis Centre | Klang | Selangor |
| Malaysia | Hospital Kota Bharu | Kota Bharu | Kelantan |
| Malaysia | Hospital Queen Elizabeth | Kota Kinabalu | Sabah |
| Malaysia | Persatuan Buah Pinggang Sabah | Kota Kinabalu | Sabah |
| Malaysia | Hospital Kuala Lumpur | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | Pantai Medical Centre, Kuala Lumpur | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | Pusat Hemodialisis, Yayasan Felda | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | SP Menon Dialysis Centre | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | The Kidney Dialysis Centre | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | Tung Shin Hospital | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | Hospital Kuala Terengganu | Kuala Terengganu | Terengganu |
| Malaysia | Hospital Tengku Ampuan Afzan | Kuantan | Pahang |
| Malaysia | Pahang Buddhist Association | Kuantan | Pahang |
| Malaysia | Hospital Umum Sarawak | Kuching | Sarawak |
| Malaysia | MAA Medicare Kidney Charity Dialysis Centre | Kuching | Sarawak |
| Malaysia | Timberland Medical Centre | Kuching | Sarawak |
| Malaysia | Hospital Melaka | Melaka | |
| Malaysia | Haemodialysis Unit , Sunway Medical Centre | Petaling Jaya | Selangor |
| Malaysia | SP Menon Dialysis Centre, Megah Medical Specialist Centre | PJ | Selangor |
| Malaysia | Pontian Rotary Haemodialysis Centre | Pontian | Johor |
| Malaysia | Penang General Hospital | Pulau Pinang | |
| Malaysia | Pusat Hemodialisis Mawar (Seremban) | Seremban | Negeri Sembilan |
| Malaysia | Seremban General Hospital | Seremban | Negeri Sembilan |
| Malaysia | Hospital Taiping | Taiping | Perak |
| Lead Sponsor | Collaborator |
|---|---|
| Ministry of Health, Malaysia |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | • To compare GerEpo with Eprex® with respect to their respective frequency of adverse events | |||
| Secondary | To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy. |