Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation - Full Text View

Sponsors and Collaborators:	Vanderbilt University Genzyme
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00305396

Purpose

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.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Sirolimus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Patient and graft survival
Biopsy proven acute rejection
Serum creatinine

Secondary Outcome Measures:

Hyperlipidemia
post-transplant diabetes
wound infections
lymphoceles

Estimated Enrollment:	80
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2005

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

HIV HCV Pregnancy Age < 18 years Malignancy

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305396

Locations

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

Sponsors and Collaborators

Vanderbilt University

Genzyme

Investigators

Principal Investigator:

A. Tarik Kizilisik, M.D.

Vanderbilt University

More Information

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.

Study ID Numbers:	031041
Study First Received:	March 20, 2006
Last Updated:	March 20, 2006
ClinicalTrials.gov Identifier:	NCT00305396 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Kidney transplantation
immunosuppression
sirolimus
Thymoglobulin

Study placed in the following topic categories:

Sirolimus
Anti-Infective Agents
Anti-Bacterial Agents

Immunologic Factors
Antifungal Agents
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 24, 2009