Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

Phase 4

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00305396
• Lead Sponsor: Vanderbilt University

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 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg 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 Timeline

• Study Start: 2004-04
• Study Completion: 2005-03
• Status Verified: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Last Update Submitted: 2006-03-20
• Study First Posted: 2006-03-21
• Last Update Posted: 2006-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Primary cadaver or non-HLA identical living donor kidney transplant. -

Exclusion Criteria

HIV HCV Pregnancy Age < 18 years Malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient and graft survival
Biopsy proven acute rejection
Serum creatinine

Secondary Outcome Measures

Name	Time	Method
Hyperlipidemia
post-transplant diabetes
wound infections
lymphoceles

Trial Locations

Locations (1)

Vanderbilt University Medical Center/Nashville VA; 🇺🇸 Nashville, Tennessee, United States