drugset / Trial / NCT00118742
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
RandomizedParallel-groupOpen-labelTreatment
Summary
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
Timeline
- Start
- 2005-08
- Primary completion
- 2008-07
- Completion
- 2008-12
Outcome
Met primary endpoint
registry CellCept + CNI (Tacrolimus or Cyclosporine) vs CellCept + Sirolimus; p = 0.0012; Mean Difference (Final Values) 24.9 (95% CI 14.8 to 35.0); ANCOVA NCT00118742 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | — | — |
| Comparator | Sirolimus | Small molecule | 2 mg | Oral |
| Comparator | Sirolimus | Small molecule | 4 mg | Oral |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Background | Mycophenolate Mofetil | Small molecule | 1.5 g | Oral |
Indications
No indication recorded.