Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519116
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2007-07-27
Brief Title:
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
An Open-label Concentration-controlled Randomized 6-month Study of Standard Dose Tacrolimus Sirolimus Corticosteroids Compared to Reduced-dose Tacrolimus Sirolimus Corticosteroids in Renal Allograft Recipients
Status:
COMPLETED
Status Verified Date:
2023-12
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 study evaluated renal graft function based on the calculated creatinine clearance 6 months after kidney transplantation in patients receiving either a regimen of reduced-dose tacrolimus sirolimus corticosteroids or a regimen of standard-dose tacrolimus sirolimus corticosteroids
Detailed Description:
The study evaluated renal graft function based on the calculated creatinine clearance 6 months after kidney transplantation in patients receiving either a regimen of reduced-dose tacrolimus sirolimus corticosteroids or a regimen of standard-dose tacrolimus sirolimus corticosteroids The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation
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