Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids

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.

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