Efficacy and Safety Study of GerEPO
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.
Sponsor: Ministry of Health, Malaysia
A PHASE3 clinical study on Chronic Renal Failure Related Anemia, this trial is completed. The trial is conducted by Ministry of Health, Malaysia and has accumulated 6 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Apr 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Ministry of Health, Malaysia
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Alor Star, Malaysia , Ampang, Malaysia , Batu Caves, Malaysia , Bukit Mertajam, Malaysia , Ipoh, Malaysia , Johor Bharu, Malaysia , Kangar, Malaysia , Klang, Malaysia , Kota Bharu, Malaysia , Kota Kinabalu, Malaysia and 10 more locations