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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
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.
• To compare GerEpo with Eprex® with respect to their respective frequency of adverse events
To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.
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Hospital Sultanah Aminah
Johor Bharu, Johor, Malaysia
Pontian Rotary Haemodialysis Centre
Pontian Besar, Johor, Malaysia
Hospital Alor Setar
Alor Star, Kedah, Malaysia
Hospital Kota Bharu
Kota Bharu, Kelantan, Malaysia
SP Menon Dialysis Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Pusat Hemodialisis, Yayasan Felda
Kuala Lumpur, Kuala Lumpur, Malaysia
The Kidney Dialysis Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Pantai Medical Centre, Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Tung Shin Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
...and 22 more locations