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About
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
Full description
This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study.
Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).
Enrollment
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Inclusion criteria
Incusion criteria at Randomization:
Exclusion criteria
Exclusion criteria at Randomization:
Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria
Subjects who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL; >5.6 mmol/L) at randomization.
Subjects with platelet count < 30,000/mm3.
Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
Subjects with systemic infection requiring active use of IV antibiotics.
Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents.
Subjects who require renal replacement therapy within 7 days prior to randomization.
Subjects with detectable HBV DNA at time of randomization
Subjects meeting the following criteria for acute rejection during the run in period:
Long term extension for patients in Japan:
Inclusion criteria
Exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
285 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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