Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Inclusion Criteria:

• Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
• The renal cold ischemic time (CIT) must be <30 hours
• The age of the donor must be between 10 and 65 years

Exclusion Criteria

• Patients who have previously received an organ transplant
• Patients who are recipients of a multiple organ transplants
• Recipients of non heart-beating donor organs
• ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.