Valentin Goutaudier, Marta Sablik, Maud Racapé, Olivia Rousseau, Benoit Audry, Nassim Kamar, Marc Raynaud, Olivier Aubert, Béatrice Charreau, Emmanuelle Papuchon, Richard Danger, Laurence Letertre, Lionel Couzi, Emmanuel Morelon, Moglie Le Quintrec, Jean-Luc Taupin, Eric Vicaut, Christophe Legendre, Hoa Le Mai, Vishnu Potluri, Thi-Van-Ha Nguyen, Marie-Eliane Azoury, Alice Pinheiro, Georges Nouadje, Pierre Sonigo, Dany Anglicheau, Ineke Tieken, Serge Vogelaar, Christian Jacquelinet, Peter Reese, Pierre-Antoine Gourraud, Sophie Brouard, Carmen Lefaucheur, Alexandre Loupy
{"title":"Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection","authors":"Valentin Goutaudier, Marta Sablik, Maud Racapé, Olivia Rousseau, Benoit Audry, Nassim Kamar, Marc Raynaud, Olivier Aubert, Béatrice Charreau, Emmanuelle Papuchon, Richard Danger, Laurence Letertre, Lionel Couzi, Emmanuel Morelon, Moglie Le Quintrec, Jean-Luc Taupin, Eric Vicaut, Christophe Legendre, Hoa Le Mai, Vishnu Potluri, Thi-Van-Ha Nguyen, Marie-Eliane Azoury, Alice Pinheiro, Georges Nouadje, Pierre Sonigo, Dany Anglicheau, Ineke Tieken, Serge Vogelaar, Christian Jacquelinet, Peter Reese, Pierre-Antoine Gourraud, Sophie Brouard, Carmen Lefaucheur, Alexandre Loupy","doi":"10.1007/s10654-024-01112-w","DOIUrl":null,"url":null,"abstract":"<p>There is an unmet need for robust and clinically validated biomarkers of kidney allograft rejection. Here we present the KTD-Innov study (ClinicalTrials.gov, NCT03582436), an unselected deeply phenotyped cohort of kidney transplant recipients with a holistic approach to validate the clinical utility of precision diagnostic biomarkers. In 2018–2019, we prospectively enrolled consecutive adult patients who received a kidney allograft at seven French centers and followed them for a year. We performed multimodal phenotyping at follow-up visits, by collecting clinical, biological, immunological, and histological parameters, and analyzing a panel of 147 blood, urinary and kidney tissue biomarkers. The primary outcome was allograft rejection, assessed at each visit according to the international Banff 2019 classification. We evaluated the representativeness of participants by comparing them with patients from French, European, and American transplant programs transplanted during the same period. A total of 733 kidney transplant recipients (64.1% male and 35.9% female) were included during the study. The median follow-up after transplantation was 12.3 months (interquartile range, 11.9–13.1 months). The cumulative incidence of rejection was 9.7% at one year post-transplant. We developed a distributed and secured data repository in compliance with the general data protection regulation. We established a multimodal biomarker biobank of 16,736 samples, including 9331 blood, 4425 urinary and 2980 kidney tissue samples, managed and secured in a collaborative network involving 7 clinical centers, 4 analytical platforms and 2 industrial partners. Patients' characteristics, immune profiles and treatments closely resembled those of 41,238 French, European and American kidney transplant recipients. The KTD-Innov study is a unique holistic and multidimensional biomarker validation cohort of kidney transplant recipients representative of the real-world transplant population. Future findings from this cohort are likely to be robust and generalizable.</p>","PeriodicalId":11907,"journal":{"name":"European Journal of Epidemiology","volume":"2012 1","pages":""},"PeriodicalIF":7.7000,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Epidemiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10654-024-01112-w","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
There is an unmet need for robust and clinically validated biomarkers of kidney allograft rejection. Here we present the KTD-Innov study (ClinicalTrials.gov, NCT03582436), an unselected deeply phenotyped cohort of kidney transplant recipients with a holistic approach to validate the clinical utility of precision diagnostic biomarkers. In 2018–2019, we prospectively enrolled consecutive adult patients who received a kidney allograft at seven French centers and followed them for a year. We performed multimodal phenotyping at follow-up visits, by collecting clinical, biological, immunological, and histological parameters, and analyzing a panel of 147 blood, urinary and kidney tissue biomarkers. The primary outcome was allograft rejection, assessed at each visit according to the international Banff 2019 classification. We evaluated the representativeness of participants by comparing them with patients from French, European, and American transplant programs transplanted during the same period. A total of 733 kidney transplant recipients (64.1% male and 35.9% female) were included during the study. The median follow-up after transplantation was 12.3 months (interquartile range, 11.9–13.1 months). The cumulative incidence of rejection was 9.7% at one year post-transplant. We developed a distributed and secured data repository in compliance with the general data protection regulation. We established a multimodal biomarker biobank of 16,736 samples, including 9331 blood, 4425 urinary and 2980 kidney tissue samples, managed and secured in a collaborative network involving 7 clinical centers, 4 analytical platforms and 2 industrial partners. Patients' characteristics, immune profiles and treatments closely resembled those of 41,238 French, European and American kidney transplant recipients. The KTD-Innov study is a unique holistic and multidimensional biomarker validation cohort of kidney transplant recipients representative of the real-world transplant population. Future findings from this cohort are likely to be robust and generalizable.
期刊介绍:
The European Journal of Epidemiology, established in 1985, is a peer-reviewed publication that provides a platform for discussions on epidemiology in its broadest sense. It covers various aspects of epidemiologic research and statistical methods. The journal facilitates communication between researchers, educators, and practitioners in epidemiology, including those in clinical and community medicine. Contributions from diverse fields such as public health, preventive medicine, clinical medicine, health economics, and computational biology and data science, in relation to health and disease, are encouraged. While accepting submissions from all over the world, the journal particularly emphasizes European topics relevant to epidemiology. The published articles consist of empirical research findings, developments in methodology, and opinion pieces.