Study Protocol: A Pilot Study to Determine the Safety and Efficacy of Induction-Therapy, De Novo MPA and Delayed mTOR-Inhibition in Liver Transplant Recipients with Impaired Renal Function. PATRON-Study

BMC Nephrology

Study Protocol

Justine Rochon¹  Marcus N Scherer²  Edward K Geissler²  Hans J Schlitt²  Andreas A Schnitzbauer²  Aiman Obed²  Johannes Sothmann²  Stefan A Farkas²  Martin Loss² 

[1] Center for Clinical Studies, Regensburg University Hospital, Regensburg, Germany;Department of Surgery, Regensburg University Hospital, Regensburg, Germany;

关键词: Liver Transplantation;    Acute Rejection;    Sirolimus;    Basiliximab;    Liver Allograft;   

DOI  :  10.1186/1471-2369-11-24

 received in 2009-11-04, accepted in 2010-09-14,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPatients 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 "bottom-up" regimens in patients with impaired renal function undergoing liver transplantation. This is a single-center study pilot-study (PATRON07) investigating safety and efficacy of CNI-free, "bottom-up" immunosuppressive (IS) strategy in patients undergoing liver transplantation (LT) with renal impairment prior to LT.Methods/DesignPatients older than 18 years with renal impairment at the time of liver transplantation eGFR < 50 ml/min and/or serum creatinine levels > 1.5 mg/dL will be included. Patients in will receive a CNI-free combination therapy (basiliximab, MMF, steroids and delayed Sirolimus). Primary endpoint is the incidence of steroid resistant acute rejection within the first 30 days after LT. 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 endpoint the regimen is regarded to be safe and efficient.DiscussionIf a CNI-free-"bottom-up" IS strategy is safe and effective, this may be an innovative concept in contrast to classic top-down strategies that could improve the patient short and long-time renal function as well as overall complications and survival after LT. The results of PATRON07 may be the basis for a large multicenter RCT investigating the new "bottom-up" immunosuppressive strategy in patients with poor renal function prior to LT.http://www.clinicaltrials.gov-identifier: NCT00604357

【 授权许可】

CC BY   
© Schnitzbauer et al; licensee BioMed Central Ltd. 2010