Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252655
Status:
UNKNOWN
Last Update Posted:
2007-04-19
First Post:
2005-11-09
Brief Title:
Use of Sirolimus vs Tacrolimus For African-American Renal Transplant Recipients
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Use of Sirolimus Vs Tacrolimus As The Primary Agent In Immunosuppressive Regimen For African-American Renal Allograft Recipients With Immediate Graft Function A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 this study is to evaluate the efficacy of Sirolimus Rapamune in improving the function of the transplant kidney without any increase in the risk of acute rejection or adverse side effects compared with Tacrolimus Prograf
We hypothesize that Sirolimus as one component of a long-term steroid-free immunosuppressive regimen will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function
We hypothesize that Sirolimus as one component of a long-term steroid-free immunosuppressive regimen will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function
Detailed Description:
It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians This has been attributed to various immunologic and non-immunologic factors including a greater rate of acute rejection resistance to standard doses of calcineurin inhibitors CNIs and corticosteroids different pharmacokinetic and pharmacodynamic profiles and noncompliance It has therefore been suggested that quadruple immunosuppression including antilymphocyte antibodies for induction should be used in this high-risk population to improve graft survival CNIs are currently the mainstay of immunosuppressive regimens Tacrolimus has been shown to be significantly more effective than Cyclosporine A in preventing acute rejection As a result Tacrolimus has become the CNI of choice in preventing acute rejection and has produced similar graft survival rates at one year with higher creatinine clearances However there is no report examining the efficacy of Sirolimus in improving renal function and its side effect profile when compared with Tacrolimus in renal allograft recipients particularly in African-Americans with immediate graft function in a steroid-free environment
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