Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion criteria:

• Patients who participated in and completed study CRAD001A2420

Exclusion criteria:

• Premature study or study treatment discontinuation in CRAD001A2420 study.

• Acute rejection within the 3 months prior to inclusion

Other protocol-defined inclusion/exclusion criteria may apply