Efficacy and Safety Study of GerEPO
- Conditions
- Chronic Renal Failure Related Anemia
- Registration Number
- NCT00229099
- Lead Sponsor
- Ministry of Health, Malaysia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy. • To compare GerEpo with Eprex® with respect to their respective frequency of adverse events
Trial Locations
- Locations (31)
Hospital Sultanah Aminah
🇲🇾Johor Bharu, Johor, Malaysia
Hospital Alor Setar
🇲🇾Alor Setar, Kedah, Malaysia
Hospital Kota Bharu
🇲🇾Kota Bharu, Kelantan, Malaysia
Haemodialysis Unit , Sunway Medical Centre
🇲🇾Petaling Jaya, Selangor, Malaysia
Pontian Rotary Haemodialysis Centre
🇲🇾Pontian, Johor, Malaysia
SP Menon Dialysis Centre, Megah Medical Specialist Centre
🇲🇾PJ, Selangor, Malaysia
The Kidney Dialysis Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Pahang Buddhist Association
🇲🇾Kuantan, Pahang, Malaysia
Hospital Kangar
🇲🇾Kangar, Perlis, Malaysia
Hospital Taiping
🇲🇾Taiping, Perak, Malaysia
Tung Shin Hospital
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Hospital Ipoh
🇲🇾Ipoh, Perak, Malaysia
MAA Medicare Kidney Charity Dialysis Centre
🇲🇾Kuching, Sarawak, Malaysia
Hospital Selayang
🇲🇾Batu Caves, Selangor, Malaysia
Hospital Melaka
🇲🇾Melaka, Malaysia
Ampang Putri Specialist Hospital
🇲🇾Ampang, Selangor, Malaysia
Asia Renal Care,Bukit Mertajam
🇲🇾Bukit Mertajam, Pulau Pinang, Malaysia
Pusat Hemodialisis Mawar (Seremban)
🇲🇾Seremban, Negeri Sembilan, Malaysia
Seremban General Hospital
🇲🇾Seremban, Negeri Sembilan, Malaysia
Hospital Queen Elizabeth
🇲🇾Kota Kinabalu, Sabah, Malaysia
Timberland Medical Centre
🇲🇾Kuching, Sarawak, Malaysia
Hospital Umum Sarawak
🇲🇾Kuching, Sarawak, Malaysia
Hospital Tengku Ampuan Rahimah
🇲🇾Klang, Selangor, Malaysia
Pantai Medical Centre, Kuala Lumpur
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Penang General Hospital
🇲🇾Pulau Pinang, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
Persatuan Buah Pinggang Sabah
🇲🇾Kota Kinabalu, Sabah, Malaysia
SP Menon Dialysis Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Hospital Kuala Terengganu
🇲🇾Kuala Terengganu, Terengganu, Malaysia
Pusat Hemodialisis, Yayasan Felda
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia