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

• Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
• Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
• Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio

To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.

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.