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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
1 mg q12 everolimus (Certican) po starting on 10th post-operative day
Prednisolone 1mg per kg body weight starting within 24 hours after transplantation. Then q24 but with reduction by 5 mg every 48 hours until maintenance dose of 7.5 mg
University Medical Center Goettingen
Göttingen, Germany
RECRUITINGSteroid resistant rejection
Time frame: 30 days
Steroid resistant rejection
Time frame: 1 year
Liver function
Time frame: 1 year
Calculated glomerular filtration rate
Time frame: 1 year
Patient survival
Time frame: 1 year
Number of days on renal replacement therapy
Time frame: 1 year
Graft survival
Time frame: 1 year
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