Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation (CILT)

Armin Goralczyk

Status and phase: Unknown; Phase 2

Conditions: Liver Transplantation; Chronic Renal Insufficiency

Treatments: Drug: Myfortic; Drug: Basiliximab (Simulect); Drug: Prednisolone; Drug: everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00890253

CILT08

Details and patient eligibility

About

A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing primary liver transplantation.
2. Patients older than 18 years.
3. Patients with a hepatorenal syndrome.
4. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
5. eGFR < 50 ml/min at the time point of transplantation.
6. Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.

Exclusion criteria

1. Patients with pre-transplant renal replacement therapy > 14 days.
2. Patients with a reason for renal impairment other than a hepatorenal syndrome.
3. Patients with a known hypersensitivity to mTOR-inhibitors.
4. Patients with a known hypersensitivity to mycophenolate acid.
5. Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
6. Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.
7. Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
8. Severe systemic infections and wound-healing disturbances.
9. Multiple organ graft recipients.
10. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
11. Pregnant women will not be included in the study.
12. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
13. Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

CNI-free Immunosuppression

Experimental group

Description:

Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.

Treatment:

Drug: everolimus

Drug: Prednisolone

Drug: Myfortic

Drug: Basiliximab (Simulect)