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A multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and torque teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation: TTVguideIT
F. Haupenthal, J. Rahn, F. Maggi, F. Gelas, P. Bourgeois, C. Hugo, B. Jilma, GA. Böhmig, H. Herkner, M. Wolzt, K. Doberer, M. Vossen, D. Focosi, H. Neuwirt, M. Banas, B. Banas, K. Budde, O. Viklicky, P. Malvezzi, L. Rostaing, JI. Rotmans, SJL....
Language English Country England, Great Britain
Document type Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase II, Journal Article
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BioMedCentral
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Directory of Open Access Journals
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- MeSH
- Adult MeSH
- Immunosuppressive Agents adverse effects MeSH
- Immunosuppression Therapy MeSH
- Quality of Life MeSH
- Humans MeSH
- Graft Rejection diagnosis prevention & control MeSH
- Tacrolimus adverse effects MeSH
- Torque teno virus * MeSH
- Kidney Transplantation * adverse effects MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Immunosuppression after kidney transplantation is mainly guided via plasma tacrolimus trough level, which cannot sufficiently predict allograft rejection and infection. The plasma load of the non-pathogenic and highly prevalent torque teno virus (TTV) is associated with the immunosuppression of its host. Non-interventional studies suggest the use of TTV load to predict allograft rejection and infection. The primary objective of the current trial is to demonstrate the safety, tolerability and preliminary efficacy of TTV-guided immunosuppression. METHODS: For this purpose, a randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, investigator-driven phase II trial was designed. A total of 260 stable, low-immunological-risk adult recipients of a kidney graft with tacrolimus-based immunosuppression and TTV infection after month 3 post-transplantation will be recruited in 13 academic centres in six European countries. Subjects will be randomised in a 1:1 ratio (allocation concealment) to receive tacrolimus either guided by TTV load or according to the local centre standard for 9 months. The primary composite endpoint includes the occurrence of infections, biopsy-proven allograft rejection, graft loss, or death. The main secondary endpoints include estimated glomerular filtration rate, graft rejection detected by protocol biopsy at month 12 post-transplantation (including molecular microscopy), development of de novo donor-specific antibodies, health-related quality of life, and drug adherence. In parallel, a comprehensive biobank will be established including plasma, serum, urine and whole blood. The date of the first enrolment was August 2022 and the planned end is April 2025. DISCUSSION: The assessment of individual kidney transplant recipient immune function might enable clinicians to personalise immunosuppression, thereby reducing infection and rejection. Moreover, the trial might act as a proof of principle for TTV-guided immunosuppression and thus pave the way for broader clinical applications, including as guidance for immune modulators or disease-modifying agents. TRIAL REGISTRATION: EU CT-Number: 2022-500024-30-00.
bioMérieux SA Centre Christophe Merieux Grenoble France
Charité Universitätsmedizin Berlin Berlin Germany
Clinical Trials Coordination Centre Medical University of Vienna Vienna Austria
Department of Clinical Pharmacology Medical University of Vienna Vienna Austria
Department of Emergency Medicine Medical University of Vienna Vienna Austria
Department of Internal Medicine Leiden University Medical Center Leiden The Netherlands
Department of Nephrology University Hospital Regensburg Regensburg Germany
Department of Philosophy 1 FiloLab UGR University of Granada Granada Spain
Division of Nephrology Department of Internal Medicine Medical University of Graz Graz Austria
Institute for Advanced Social Studies Spanish National Research Council Madrid Spain
Laboratory of Virology National Institute for Infectious Diseases L Spallanzani Rome Italy
North Western Tuscany Blood Bank Pisa Italy
Ordensklinikum Linz GmbH Elisabethinen Linz Austria
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden Germany
References provided by Crossref.org
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