drugset / Trial / NCT00371826

SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

NCT00371826

Phase 4 Completed 126 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Timeline

Start
2006-03
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 5 mg/kg
Subject Everolimus Small molecule 1.5 mg
Subject Methylprednisone Unknown
Subject Mycophenolate Sodium Unknown 720 mg
Subject Prednisone Other / unclassified