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AI for Allograft Diseases Diagnosis and Prognosis After Kidney Transplantation

AI for Allograft Diseases Diagnosis and Prognosis After Kidney Transplantation

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05112770
Acronym
AI4ADAPT
Enrollment
0
Registered
2021-11-09
Start date
2022-01-04
Completion date
2027-08-31
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplantation, Acute renal transplant rejection, Urinary concentrations of chemokines, Multiparametric models, Artificial intelligence

Brief summary

Kidney transplantation is the treatment of choice for patients with end stage renal disease. One of the major challenges is to better diagnose the attacks undergone by the kidney transplant in order to increase its longevity. Multiple attacks are caused by non-immune and immune mechanisms, first and foremost the acute rejection of the transplant. Biopsy, an invasive method, remains the Gold Standard for diagnosing rejection and other pathologies affecting the kidney transplant. The invasive nature of these biopsies limits their use and alternative biomarkers have been evaluated in order to diagnose kidney transplant pathologies in a non-invasive manner. It is in this context that the nephrology and renal transplantation department of the Necker hospital and Inserm U1151 have carried out several studies leading to the identification of the diagnostic and prognostic potential of acute rejection, by the determination of urinary concentrations of two chemokines, CXCL9 and CXCL10. The most recent study conducted within these teams demonstrated that the diagnostic potential of urinary chemokines could be improved by taking into account standard clinicobiological parameters in multiparametric models. The main objective of the study is to develop, train and validate artificial intelligence models including urinary chemokines, efficient, robust, explainable and interpretable for the diagnosis and non-invasive prognosis of acute renal transplant rejection, trained on a data set made up of clinical and biological parameters.

Detailed description

Kidney transplantation is the treatment of choice for patients with end stage renal disease. One of the major challenges is to better diagnose the attacks undergone by the kidney transplant in order to increase its longevity. Multiple attacks are caused by non-immune and immune mechanisms, first and foremost the acute rejection of the transplant. Biopsy, an invasive method, remains the Gold Standard for diagnosing rejection and other pathologies affecting the kidney transplant. The invasive nature of these biopsies limits their use and alternative biomarkers have been evaluated in order to diagnose kidney transplant pathologies in a non-invasive manner. It is in this context that the nephrology and renal transplantation department of the Necker hospital and Inserm U1151 have carried out several studies leading to the identification of the diagnostic and prognostic potential of acute rejection, by the determination of urinary concentrations of two chemokines, CXCL9 and CXCL10. The most recent study conducted within these teams demonstrated that the diagnostic potential of urinary chemokines could be improved by taking into account standard clinicobiological parameters in multiparametric models. The main objective of the study is to develop, train and validate artificial intelligence models including urinary chemokines, efficient, robust, explainable and interpretable for the diagnosis and non-invasive prognosis of acute renal transplant rejection, trained on a data set made up of clinical and biological parameters. For this, all the clinical parameters (demographic, medical history, characteristics of donors, immunosuppressive treatments, etc.) and biological (follow up of the usual biological parameters obtained as part of the routine care of transplant patients, urinary chemokines) of transplant patients followed in the nephrology and renal transplantation department of Necker hospital between 2004 and 2020, will be treated without a priori and by artificial intelligence methods.

Interventions

None listed

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All renal transplant patients whose medical follow-up is provided by the nephrology and adult renal transplantation department of the Necker hospital between 2004 and 12/31/2020; * Patient having signed a consent form for the storage, use and transfer of samples taken during treatment, for scientific research purposes; * Patient not objecting to the processing of his personal data as part of the study.

Exclusion criteria

\- A deceased patient who, during his lifetime, objected in writing to the processing of his data for research purposes.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic model accuracy3 yearsROC (receiver operating characteristic) curves AUC (Area under the Curve)
Prognostic model accuracy3 yearsC-statistics

Secondary

MeasureTime frameDescription
Strenght of the models3 yearsSensitivity analyses comparing the AUC values and the calibration of the models in various clinical scenarios.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026