Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229099
Status:
COMPLETED
Last Update Posted:
2006-10-26
First Post:
2005-09-28
Brief Title:
Efficacy and Safety Study of GerEPO
Sponsor:
Ministry of Health Malaysia
Organization:
Ministry of Health Malaysia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion 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 10000 patient-years of observation have accrued on the study database
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 10000 patient-years of observation have accrued on the study database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None