Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
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

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
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

-

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305396
031041
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