Avoidance of initial overimmunosuppression in very sick patients after liver transplantation.

Conditions: iver transplantation, renal function, high MELD scores, infections, bottom-up immunosuppression
MedDRA version: 16.1Level: PTClassification code 10062016Term: ImmunosuppressionSystem Organ Class: 10021428 - Immune system disorders
MedDRA version: 16.1Level: LLTClassification code 10021523Term: Impaired renal functionSystem Organ Class: 100000004857
MedDRA version: 16.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865

Registration Number: EUCTR2009-017192-26-DE

Lead Sponsor: Free State of Bavaria represented by Regensburg University represented by Regensburg University Hospital represented by

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1.Male and female liver transplant recipients of a primary liver transplant older than 18 years
2.Signed, written informed consent prior to randomization
3.MELD scores =25
4.Lack of relevant exclusion criteria

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients transplanted for autoimmune hepatitis
2.HIV positive patients
3.Patients with pre-transplant immunosuppressive treatment
4.Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant.
5.Patients with renal failure or CKD/ESRD who require renal replacement therapy for more than 2 weeks prior to transplantation.
6.Patients with signs of hepatic artery thrombosis.
7.Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
8.Patients who are recipients of ABO incompatible transplant grafts.
9.Patients with uncontrolled or therapy refractory hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) at time of transplantation.