At a glance
ClinicalIndex Comparison Record- ✓Age 18–74 years
- ✓Single primary liver transplant from a deceased donor
- ✓On CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
- ✓Hepatitis C-positive patients require intraoperative or pre-randomization biopsy of transplanted liver
- ✕Liver allograft from living donor or split liver
- ✕Multiple organ transplant
- ✕Dialysis therapy for more than 14 days from transplantation to randomization
- ✕History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of a Long-term Calcineurin Inhibitor-free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant
In Brief
A Phase 4 clinical trial evaluating mycophenolate mofetil [CellCept], Tacrolimus, and 2 other interventions for Liver Transplantation. Completed, enrolled 293 participants across 46 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
1-1.5 g orally or intravenously twice daily
As prescribed, for 12 months
As prescribed, for 12 months
2-4 mg orally once daily for 9-11 months