drugset / Trial / NCT00425308

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.

NCT00425308

Phase 3 Completed 30 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2006-10
Primary completion
2009-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide
Comparator Everolimus Small molecule
Comparator Mycophenolate Sodium Unknown 360 mg

Indications

No indication recorded.