Phase 4
N=293
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00118742 ↗Enrolled (actual)
293
Serious AEs
44.9%
Results posted
Mar 2010
Primary outcome: Primary: Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant — 1.2; 19.7 Percent change in GFR (mL/min) — p=0.0012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- mycophenolate mofetil [CellCept] (Drug); Tacrolimus (Drug); Cyclosporine (Drug); Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant |
1.2; 19.7 | 0.0012 sig |
| SECONDARY Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant |
1.1; 25.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant |
-8.6; 13.5 | 0.0053 sig |
| SECONDARY Change From Baseline in Creatinine Clearance |
-1.3; 18.5; -3.0; 14.0; -12.8; 7.9 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients 18-74 years of age
- Single primary liver transplant from a deceased donor
- CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
- Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.
Exclusion Criteria
- Liver allograft from a living donor or a split liver
- Multiple organ transplant
- Dialysis therapy for >14 days from transplantation to randomization
- History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
- Previous sirolimus therapy
Data sourced from ClinicalTrials.gov (NCT00118742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.