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Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: Sirolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
A. Tarik Kizilisik, M.D., Principal Investigator, Affiliation: Vanderbilt University

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.

Clinical Details

Official title: Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Patient and graft survival

Biopsy proven acute rejection

Serum creatinine

Secondary outcome:

Hyperlipidemia

post-transplant diabetes

wound infections

lymphoceles

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria: HIV HCV Pregnancy Age < 18 years Malignancy

-

Locations and Contacts

Vanderbilt University Medical Center/Nashville VA, Nashville, Tennessee 37232, United States
Additional Information

Related publications:

Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6.

Starting date: April 2004
Last updated: March 20, 2006

Page last updated: August 23, 2015

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