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Table 1 Criteria for inclusion and exclusion of patients.

From: A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT

Inclusion criteria

Exclusion criteria

1. Patients undergoing primary liver transplantation.

1. Pregnant or nursing women.

2. Patients older than 18 years.

2. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.

3. Patients with a hepatorenal syndrome.

3. Patients under guardianship, i. e., individuals who are not able to freely give their informed consent.

4. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation. †

4. Patients with pre-transplant renal replacement therapy > 14 days.

5. eGFR < 50 ml/min at the time point of transplantation.

5. Patients with a reason for renal impairment other than a hepatorenal syndrome.

6. Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.

6. Patients with a known hypersensitivity to any of the investigational medicinal products.

 

7. Patients with thrombocytopenia (<50.000/nl), hypertriglyceridemia (> 350 mg/dl), or hypercholesterinemia (> 300 mg/dl), and patients with signs of hepatic artery stenosis prior to initiation of therapy with everolimus.

  1. † A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1 per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partners in accordance to CPMP/ICH/286/95.