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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
293
1-1.5 g orally or intravenously twice daily
As prescribed, for 12 months
As prescribed, for 12 months
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Time frame: 12 months posttransplant
Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Time frame: 6 months posttransplant
Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Time frame: 24 months posttransplant
Change From Baseline in Creatinine Clearance
Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation
Time frame: 6, 12, and 24 months posttransplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2-4 mg orally once daily for 9-11 months
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Jacksonville, Florida, United States
...and 36 more locations