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Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

This study has been completed.
Genzyme, a Sanofi Company
Information provided by:
Vanderbilt University Identifier:
First received: March 20, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted

March 20, 2006
March 20, 2006
April 2004
Not Provided
  • Patient and graft survival
  • Biopsy proven acute rejection
  • Serum creatinine
Same as current
No Changes Posted
  • Hyperlipidemia
  • post-transplant diabetes
  • wound infections
  • lymphoceles
Same as current
Not Provided
Not Provided
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.
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.
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.
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Drug: Sirolimus
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

HIV HCV Pregnancy Age < 18 years Malignancy

18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Vanderbilt University
Genzyme, a Sanofi Company
Principal Investigator: A. Tarik Kizilisik, M.D. Vanderbilt University
Vanderbilt University
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP