Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer160 enrolled

Overview

Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Graft Rejection Kidney Failure Kidney Transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 and \< 65 years * End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor * Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant Exclusion Criteria: * Evidence of active systemic or localized major infection at the time of initial sirolimus administration * Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening * Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

Outcomes

Primary Outcomes

- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-

transplantation.

Secondary Outcomes

Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff

criteria at 3, 6 and 12 Months following transplantation

One year graft biopsy status

Incidence of document infection