Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection.

Biomarkers Cohort profile Kidney transplantation Rejection Study design

Journal

European journal of epidemiology

ISSN: 1573-7284

Titre abrégé: Eur J Epidemiol

Pays: Netherlands

ID NLM: 8508062

Informations de publication

Date de publication:
16 Apr 2024

Historique:

received: 27 11 2023

accepted: 04 03 2024

medline: 16 4 2024

pubmed: 16 4 2024

entrez: 16 4 2024

Statut: aheadofprint

Résumé

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.

Identifiants

DOI: 10.1007/s10654-024-01112-w PMID: 38625480

pubmed: 38625480

doi: 10.1007/s10654-024-01112-w

pii: 10.1007/s10654-024-01112-w

doi:

Banques de données

ClinicalTrials.gov

['NCT03582436']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Subventions

Organisme : Agence Nationale de la Recherche

ID : ANR-17-RHUS-0010

Informations de copyright

Références

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