Status:
COMPLETED
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief 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. Patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00118742
Start Date
August 1 2005
End Date
December 1 2008
Last Update
August 3 2010
Active Locations (46)
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1
Birmingham, Alabama, United States, 35294
2
Phoenix, Arizona, United States, 85054
3
La Jolla, California, United States, 92037
4
Los Angeles, California, United States, 90033-4612