drugset / Trial / NCT00371826
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |