Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 11:27 AM
Study NCT ID:
NCT00478608
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Rapamune® Maintenance Regimen
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
Secondary :
1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
Secondary :
1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: