Inclusion criteria | Exclusion criteria |
---|---|
1. Patients able to give written informed consent to participate in the study | 1. Recipients of multiple solid organ transplants |
2. Male or female recipients 18–65 years with full-size liver allograft | 2. Patients with renal failure or CKD/ESRD requiring renal replacement therapy for more than 2 weeks prior to transplantation |
3. Negative pregnancy test (females of child bearing age) | 3. History of malignancy within the past 5Â years |
4. HCC that does not fulfill the Milan criteria at the time of transplantation | |
5. Patients with a known hypersensitivity to the drugs used in the study or their class, or to any of the excipients | |
6. Recipients of ABO incompatible transplant grafts | |
7. HIV positive patients | |
8. Patients with a current systemic infection or sepsis requiring active use of intravenous antibiotics | |
At randomization (Day 7–21 post-liver transplantation) | |
1. eGFR (MDRD4 formula) >30Â mL/min/1.73Â m2 | 1. Platelet count <50,000/mm3, absolute neutrophil count <1,000/mm3, or a white blood cell count <2,000/mm3 |
2. Absence of thrombosis prior to any initiation of treatment with everolimus | 2. Hemoglobin <8.0Â g/dL |
3. Functioning allograft (total bilirubin levels ≤3 times ULN, and AP, AST, and ALT levels ≤5 times ULN) | 3. Uncontrolled hypercholesterolemia or hypertriglyceridemia |
4. Proteinuria >1Â g/24Â hours | |
5. Patients with infections requiring active use of intravenous antibiotics |