Study Evaluating Sirolimus in Kidney Transplant Recipients.

A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.

Renal function at 12 months assessed by calculated creatinine clearance.

Inclusion Criteria:

• Age is older than 18 years.
• End-stage renal disease, with subjects scheduled for kidney transplant.
• Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusion applies.

Exclusion Criteria:

• Evidence of active systemic or localized major infection.
• Use of any investigational drug or treatment up to 4 weeks prior to study entry.
• Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
• Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
• Immunosuppression therapies other than those allowed in the protocol.
• Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.

Other exclusion applies.