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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00305396
Other study ID # 031041
Secondary ID
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
Est. primary completion date
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


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
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