Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

Inclusion Criteria: * Male or female aged above 18 years. * Patients having received their first or second single renal transplant from deceased or living donor * Patient willing and capable of giving written informed consent for study participation * Patients treated with as induction therapy at the time of transplantation * Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg * Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant * Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility. Exclusion Criteria: * Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant * Patients with antibodies towards the donor kidney above 30% * Patients receiving a renal transplant from HLA-identical sibling * Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides) * Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin * Patients who are recipients of AB0 incompatible transplants * Patients with unsuitable laboratory values * Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator * Patient with a current severe major local or systemic infection * Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) \< 20 ml/min * Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch * Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded. * Evidence of severe liver disease Other protocol-defined inclusion/exclusion criteria may apply.