Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478608
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2007-05-24
Brief Title:
Study Evaluating Rapamune Maintenance Regimen
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
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:
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