Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305396
Status:
COMPLETED
Last Update Posted:
2006-03-21
First Post:
2006-03-20
Brief Title:
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2006-03
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:
A prospective single center open-label randomized trial of Thymoglobulin induction and sirolimus prednisone and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus prednisone and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients
Detailed Description:
Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation We conducted a prospective randomized single-center study comparing sirolimus versus tacrolimus in kidney transplantation Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD target level 8-12 ngml or tacrolimus 0075 mgkg BID target level 8-12 ngml All patients also received Thymoglobulin 15 mgkg x 4 doses mycophenolate 1 gm BID and prednisone Main outcome measures are patient and graft survival biopsy-proven acute rejection serum creatinine hyperlipidemia post-transplant diabetes and surgical and wound complications
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