A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free de-novo Immunosuppression after Liver Transplantation.

Conditions: Patients with renal dysfunction undergoing liver transplantation
MedDRA version: 14.0Level: PTClassification code 10019846Term: Hepatorenal syndromeSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.0Level: LLTClassification code 10038474Term: Renal insufficiencySystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.0Level: LLTClassification code 10024678Term: Liver failureSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders

Registration Number: EUCTR2008-008754-23-DE

Lead Sponsor: niversity Medical Center Göttingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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-CD25-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 Sirolimus.
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).