Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial

Table 2 Key inclusion and exclusion criteria for the Hephaistos study

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 5 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) >30 mL/min/1.73 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 <8.0 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 >1 g/24 hours
	5. Patients with infections requiring active use of intravenous antibiotics

ALT, alanine aminotransferase; AP, alkaline phosphatase; AST, aspartate aminotransferase; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; HCC, hepatocellular carcinoma; MDRD4, Modification of Diet in Renal Disease-4; ULN, upper limit of normal.

ISSN: 1745-6215