Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
This study will investigate the efficacy and safety of a steroid avoidance regimen in
 comparison with steroid treatment in combination with an initially higher dose of
 enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal
 transplant recipients. Patients will be randomly allocated to receive either EC-MPS or
 steroids in combination with EC-MPS. Patients of both treatment groups will receive
 monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
Inclusion Criteria:

 -  Primary donor kidney transplant

 -  Panel reactive antibody (PRA) ≤ 20%

 Exclusion Criteria:

 -  Multi-organ transplantation including dual kidneys or previous transplant with any
 other organ different from kidney

 -  Non-heart beating donor or kidney from a non-compatible donor

 Other protocol-defined inclusion/exclusion criteria may apply.