A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Inclusion Criteria:

• End-stage renal disease, with patients scheduled to receive a kidney transplant.
• Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
• Signed informed consent.

Exclusion Criteria:

• Evidence of active systemic or localized major infection at the time of initial study drug administration;
• Multiple organ transplants;
• Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.