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Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

This study has been completed.
Sponsor:
Collaborator:
Genzyme
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00305396
First received: March 20, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Resource links provided by NLM:

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:

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

Keywords provided by Vanderbilt University:
Kidney transplantation
immunosuppression
sirolimus
Thymoglobulin

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013