%0 Journal Article
%T A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT
%A Armin D Goralczyk
%A Andreas Schnitzbauer
%A Tung Y Tsui
%A Giuliano Ramadori
%A Thomas Lorf
%A Aiman Obed
%J BMC Surgery
%D 2010
%I BioMed Central
%R 10.1186/1471-2482-10-15
%X A prospective therapeutic exploratory, non-placebo controlled, two stage monocenter trial in a total of 29 liver transplant patients was designed to assess the safety and efficacy of de-novo CNI-free immunosuppression with basiliximab, mycophenolate sodium, prednisolone and everolimus. The primary endpoint is the rate of steroid resistant rejections. Secondary endpoints are the incidence of acute rejection, kidney function (assessed by incidence and duration of renal replacement therapy, incidence of chronic renal failure, and measurement glomerular filtration rate), liver allograft function (assessed by measurement of AST, ALT, total bilirubin, AP, GGT), treatment failure, (i. e., re-introduction of CNI), incidence of adverse events, and mortality up to one year after OLT.This prospective, two-stage, single-group pilot study represents an intermediate element of the research chain. If the data of the phase II study corroborates safety of de-novo CNI-free immunosuppressive regimen this should be confirmed in a randomized, prospective, controlled double-blinded clinical trial. The exploratory data from this trial may then also facilitate the design (e. g. sample size calculation) of this phase III trial.NCT00890253 (clinicaltrials.gov)Recipients of a liver allograft are at high risk of acute and subsequently chronic renal dysfunction resulting in a significantly increased risk of premature death [1,2]. After OLT more than 90% of patients receive an immunosuppressive regimen based on calcineurin inhibitors (CNI), i. e., cyclosporine A(CsA) or tacrolimus (TAC) [3]. CNI cause renal arteriolopathy resulting in histopathological and functional changes [4]. Hence, nephrotoxicity associated with CNI mitigates renal function and contributes to the increased risk of end-stage renal disease after OLT [5-7]. Strategies are needed to minimize the incidence of renal impairment after OLT.Despite major differences in the chemical structure, both, TAC and CsA, seem to cause nephropa
%U http://www.biomedcentral.com/1471-2482/10/15