eprintid: 19477
rev_number: 16
eprint_status: archive
userid: 1589
dir: disk0/00/01/94/77
datestamp: 2016-01-19 08:17:55
lastmod: 2024-03-09 18:50:11
status_changed: 2016-01-19 08:17:55
type: article
metadata_visibility: show
creators_name: Sommerer, Claudia
creators_name: Schaier, Matthias
creators_name: Morath, Christian
creators_name: Schwenger, Vedat
creators_name: Rauch, Geraldine
creators_name: Giese, Thomas
creators_name: Zeier, Martin
title: The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial
subjects: 610
divisions: 910200
divisions: 911600
divisions: 911800
abstract: Background: Adequate monitoring tools are required to optimise the immunosuppressive therapy of an individual patient. Particularly, in calcineurin inhibitors, as critical dose drugs with a narrow therapeutic range, the optimal monitoring strategies are discussed in terms of safety and efficacy. Nevertheless, no pharmacokinetic monitoring markers reflect the biological activity of the drug. A new quantitative analysis of gene expression was employed to directly measure the functional effects of calcineurin inhibition: the transcriptional activities of the nuclear factor of activated T-cell (NFAT)-regulated genes in the peripheral blood.   Methods/Design: The CIS study is a randomised prospective controlled trial, comparing a ciclosporin A (CsA)-based immunosuppressive regimen monitored by CsA trough levels to a CsA-based immunosuppressive regimen monitored by residual NFAT-regulated gene expression. Pulse wave velocity as an accepted surrogate marker of the cardiovascular risk is assessed in both study groups. Our hypothesis is that an individualised CsA therapy monitored by residual NFAT-regulated gene expression results in a significantly lower cardiovascular risk compared to CsA therapy monitored by CsA trough levels.   Discussion: There is a lack of evidence in individualising standard immunosuppression in renal allograft recipients. The CIS study will consider the feasibility of individualised ciclosporin A immunosuppression by pharmacodynamic monitoring and evaluate the opportunity to reduce cardiovascular risk while maintaining sufficient immunosuppression.   Trial registration: EudraCT identifier 2011-003547-21, registration date 18 July 2011
date: 2014
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1656158493
own_urn: urn:nbn:de:bsz:16-heidok-194775
language: eng
bibsort: SOMMERERCLTHECALCINE2014
full_text_status: public
publication: Trials
volume: 15
number: 489
place_of_pub: London
pagerange: 1-10
issn: 1468-6694
citation:   Sommerer, Claudia ; Schaier, Matthias ; Morath, Christian ; Schwenger, Vedat ; Rauch, Geraldine ; Giese, Thomas ; Zeier, Martin  (2014) The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial.  Trials, 15 (489).  pp. 1-10.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/19477/1/13063_2014_Article_2348.pdf