原创力文档a therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation cilt治疗探索性研究的有效性和安全性calcineurin-inhibitor-free新创肝移植后免疫抑制分会.pdfVIP
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a therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation cilt治疗探索性研究的有效性和安全性calcineurin-inhibitor-free新创肝移植后免疫抑制分会
Goralczyk et al. BMC Surgery 2010, 10:15
/1471-2482/10/15
STUDY PROTOCOL Open Access
A therapeutic exploratory study to determine the
efficacy and safety of calcineurin-inhibitor-free
de-novo immunosuppression after liver
transplantation: CILT
1* 2 3 4 1 1
Armin D Goralczyk , Andreas Schnitzbauer , Tung Y Tsui , Giuliano Ramadori , Thomas Lorf , Aiman Obed
Abstract
Background: Immunosuppression with calcineurin inhibitors (CNI) increases the risk of renal dysfunction after
orthotopic liver transplantation (OLT). Controlled trials have shown improvement of renal function in patients that
received delayed and/or reduced-dose CNI after OLT. Delaying immunosuppression with CNI in combination with
induction therapy does not increase the risk of acute rejection but reduces the incidence of acute renal
dysfunction. Based on this clinical data this study protocol was designed to assess the efficacy and safety of
calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation.
Methods/Design: 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-introdu
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