Efficacy and Safety Study of GerEPO
Chronic Renal Failure Related Anemia
About this trial
This is an interventional treatment trial for Chronic Renal Failure Related Anemia
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.
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