The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
607
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is \>90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Time frame: Baseline and 12 months
Patient and Graft Survival
Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.
Time frame: 12 months
Number of Patients With a Biopsy Confirmed Acute Rejection
Overall event rate is determined as yes or no.
Time frame: 12 months
Mean Serum Creatinine
Observed mean values for serum creatinine.
Time frame: 12 months
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San Francisco, California, United States
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Tampa, Florida, United States
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New Orleans, Louisiana, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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Rochester, New York, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
...and 32 more locations