Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS

Inclusion criteria 1\. Male and female patients aged 18 to 70 years 2. Patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive CsA-ME and anti-CD25 antibody as primary immunosuppression; 3. Patients able to receive the first dose of EC-MPS within 48 hours of graft reperfusion Exclusion criteria 1. Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ. 2. Recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours 3. Recipient who is HLA-identical to the donor 4. Patients with a PRA level (past or current level) higher than 50% 5. Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose). 6. Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline. 7. HIV-positive 8. Positive HBsAg test for both donor and recipients. 9. Unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure NYHA class III-IV or hemodinamically significant valvular heart disease 10. Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN 11. Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/exclusion criteria may apply