Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de Novo Renal Transplant Patients

The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.

Inclusion Criteria:

• Males or females, 18 to 65 years old
• First or second time kidney transplant patients
• For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication

Exclusion Criteria:

• Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
• Multi-organ recipients or previous transplant of another organ, different from the kidney
• Recipients from a non-heart-beating donor
• Known hypersensitivity to mycophenolic acid or cyclosporine
• HIV positive or Hepatitis B surface antigen positive
• History of malignancy (past 5 years)
• Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
• Evidence of severe liver disease

Other protocol-defined inclusion/exclusion criteria may apply.