Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

Inclusion Criteria:

• Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
• The renal cold ischemic time must be < 36 hours.
• The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

• Patients who are recipients of multiple organ transplants, including more than one kidney
• Patients who have previously received an organ transplant which failed within one year
• Patients with current panel reactive T-cell antibody titers of 50% or more
• Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.