Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305396
• Other study ID #: 031041
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2006
• Last updated: March 20, 2006
• Start date: April 2004
• Est. completion date: March 2005

Study information

• Verified date: March 2006
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

HIV HCV Pregnancy Age < 18 years Malignancy

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Sirolimus

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center/Nashville VA	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and graft survival
Primary	Biopsy proven acute rejection
Primary	Serum creatinine
Secondary	Hyperlipidemia
Secondary	post-transplant diabetes
Secondary	wound infections
Secondary	lymphoceles