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A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
Details
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 397 |
| Start date | 1999-11 |
| Completion | 2007-12 |
Conditions
- Renal Transplantation
Interventions
- tacrolimus
- CellCept
- steroids (methylprednisone or prednisone)
Primary outcomes
- Assessment of death, graft loss, or severe acute rejection — 6 months, 12 months, yearly up to 5 years
Countries
United States