Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

• Status: Completed
• Trial end date: 1969-12-31

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Prednisone