Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation
Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.