CNI-free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Background:
Patients undergoing liver transplantation with preexisting renal dysfunction are prone to
further renal impairment with the early postoperative use of Calcineurin-inhibitors. However,
there is only little scientific evidence for the safety and efficacy of de novo CNI free
regimens in patients with impaired renal function undergoing liver transplantation. The
objective of the study is to evaluate a de novo calcineurin-inhibitor-free immunosuppressive
regimen based on induction therapy with anti-CD25 monoclonal anti- body, mycophenolate
mofetil (MMF/MPA), and mTOR-inhibition to determine its safety and to investigate the
preliminary efficacy in patients with impaired renal function at the time of liver
transplantation. Methods/Design: Patients older than 18 years with renal impairment at the
time of liver transplantation due to hepatorenal syndrome, eGFR < 50 ml/min and/or serum
creatinine levels > 1.5 mg/dL will be included. Patients will receive a combination therapy
with antiCD25-monoclonal antibodies, MMF, steroids and delayed sirolimus (day 10) and will be
evaluated with regards to the incidence of steroid resistant acute rejection within the first
30 days after liver transplantation as the primary endpoint. The study is designed as
prospective two-step trial requiring a maximum of 29 patients. In the first step 9 patients
will be included. If 8 or more patients show no signs of biopsy proven steroid resistant
rejection, additional 20 patients will be included. If in the second step a total of 27 or
more patients reach the primary end-point the regimen is regarded to be safe and efficient.
The follow up period will be one year after transplantation. The aim is to obtain safety and
efficacy data for this new and innovative therapy regimen that might be the basis for a large
prospective randomized multicenter trial in the future.