Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

Inclusion Criteria:

• Male or female de novo renal transplant recipients between 18 and 65 years of age
• Patients who are receiving a primary cadaveric donor or non-human leukocyte antigen (non-HLA) identical living donor kidney transplant
• Patients who have given written informed consent to participate in the study
• Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Exclusion Criteria:

• Patients with no evidence of graft function within 24 hours of transplantation are excluded
• Recipients of dual kidney transplants
• Patients who are recipients of multiple solid organ or tissue transplants, or have previously received an organ or tissue transplant.
• Recipients of kidneys from HLA-identical living related donors
• Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. Although Panel Reactive Antibodies (PRA) test is not mandatory, patients whose most recent anti-HLA Class I PRA >20% By a CDC-(Complement dependent cytotoxicity) based assay or >50% by a Flow Cytometry or ELISA (Enzyme linked immunosorbent assay) -based assay
• Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within two weeks prior to randomization.
• Recipients of organs from donors who test positive for Hepatitis B surface antigen, HCV or HIV are excluded
• Donor organ with a cold ischemia time >24 hours
• Donor age greater than 65 years
• Patients with platelet count <100,000/mm at baseline before transplantation
• Patients with an absolute neutrophil count of < 1,500/mm³ or white blood cell count of < 4,500/mm³ at baseline before transplantation
• Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
• Patients who have an abnormal liver profile such as alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin >3 times the upper limit of normal (ULN)
• Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
• Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450
• Patients who are unable to take oral medication at time of randomization
• Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
• Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions
• Patients with clinically significant systemic infection at time of transplant or within two weeks prior to transplant
• Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
• Patients who have cardiac failure at time of screening (resting dyspnea, with Grade ≥ 3 according to Old New York Heart Association Classification (Appendix 7) or any severe cardiac disease as determined by the investigator
• Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication
• Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks prior to randomization which would interfere with the objectives of the study
• Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed)
• Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Other protocol-defined inclusion/exclusion criteria may apply