Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armin Goralczyk
• Treatments: Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Sirolimus

Criteria

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).