Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.

Inclusion criteria:

• Patients receiving a primary kidney from a donor aged > 65 years
• In the Eurotransplant Senior Program
• Recipients of de novo cadaveric kidney transplants

Exclusion criteria:

• Multi-organ recipients (e.g., kidney and pancreas)
• Patients receiving a kidney from a non-heart beating donor
• Patients who are recipients of A-B-O incompatible transplants
• Patients with already existing antibodies against the HLA-type of the receiving transplant
• Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
• Patients with thrombocytopenia, with an absolute neutrophil count of < 1,500/mm³ or leucopenia or hemoglobin < 6 g/dL
• Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
• Evidence of severe liver disease
• Females at randomization who will be not considered post-menopausal

Other protocol-defined inclusion/exclusion criteria may apply