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

URN to cite this document:

urn:nbn:de:bvb:355-epub-351217 Copy

DOI to cite this document:

10.5283/epub.35121 Copy

Schnitzbauer, Andreas A. ; Scherer, Marcus N. ; Rochon, Justine ; Sothmann, Johannes ; Farkas, Stefan A. ; Loss, Martin ; Geissler, Edward K. ; Obed, Aiman ; Schlitt, Hans J.

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Date of publication of this fulltext: 01 Feb 2017 13:02

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Details

Item type:	Article
Open Access Type:	Gold (mit APC - nicht UR)
Journal or Publication Title:	BMC Nephrology
Publisher:	BIOMED CENTRAL LTD
Place of Publication:	LONDON
Volume:	11
Number of Issue or Book Chapter:	24
Date:	14 September 2010
Institutions:	Medicine > Lehrstuhl für Chirurgie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.1186/1471-2369-11-24 DOI 20840760 PubMed ID PMC2945344 PubMedCentral-ID
Keywords:	ORGAN-TRANSPLANTATION; RISK-FACTORS; FAILURE; DISEASE; INFECTIONS; IMPACT;
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	35121

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Abstract

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 "bottom-up" regimens in patients with impaired renal function undergoing liver transplantation. This is a ...

Abstract

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 "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/Design: Patients 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. Discussion: If 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

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