Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

Inclusion Criteria:

• Recipients of primary heart transplant
• Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
• Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil

Exclusion Criteria:

• Patients who are recipients of multiple organ transplants
• Patients who have previously received an organ transplant
• Patients with serum creatinine > 3.5 mg/dl

Other protocol-defined exclusion criteria may apply.