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Kidney TransplantAITXNCT07600541

Perceptions of Kidney Transplant Recipients Regarding the Role of Artificial Intelligence in Medicine

An observational study of Kidney Transplant, run by Paris Translational Research Center for Organ Transplantation at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The AITX study is an international, multicenter survey exploring how kidney transplant recipients perceive artificial intelligence (AI) in medicine and, specifically, a system that predicts graft loss risk. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant
How many people
1,000 participants
Where
2 sitesFrance
Study dates
15 Apr 2026to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study targets adult kidney transplant recipients (≥18 years), fluent in French or English, and able to provide electronic consent. Patients with severe cognitive impairment preventing comprehension or technical inability to access the online questionnaire are excluded. Participants are recruited through transplant centers and patient associations in France and the United States. The questionnaire will be distributed to an estimated 10,000-20,000 patients, with an expected response rate of 10-15%

Who may be able to join

  • Age ≥ 18 years
  • Fluency in French or English
  • Electronic consent given

Who cannot join

  • Severe cognitive impairment preventing comprehension
  • Technical inability to access the questionnaire

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France2 sites, 2 recruiting
  • Le flambeau de la vie

    Paris, Île-de-France Region, 75015

    Michel Baujard, MSc, 06 71 19 86 27, leflambeaudelavie@gmail.com

    Recruiting
  • Nice Pasteur

    Paris, Île-de-France Region, 75015

    Nathalie Cerruti, MD, +33 4 92 03 77 77, Cerruti.n@chu-nice.fr

    Recruiting

Other trials in France

About this study

The AITX study is an international, multicenter survey exploring how kidney transplant recipients perceive artificial intelligence (AI) in medicine and, specifically, a system that predicts graft loss risk. Through an open-ended online questionnaire distributed across transplant centers and patient associations in France and the United States, the study captures patients' expectations, concerns, and the perceived impact of AI-driven prediction on their daily lives. Responses are analyzed using large language models (LLMs) with systematic human verification. The study aims to ensure that the deployment of AI in transplantation is ethical, transparent, and patient-centered.

Read the detailed description

# Study Summary

## Background

Kidney transplantation is currently the gold standard treatment for end-stage renal disease, with over 170,000 transplants performed each year worldwide. Despite major advances in short-term survival, long-term graft survival remains limited: approximately 40% of patients return to dialysis within 10 to 15 years following transplantation.

In recent years, artificial intelligence (AI) has emerged as a promising tool for predicting graft outcomes and supporting clinical decision-making. The iBox system, developed by the Paris Institute for Transplantation and Organ Regeneration, calculates a personalized probability of graft loss up to ten years after evaluation of the kidney transplant recipient.

This algorithm has been validated internationally across multiple cohorts and clinical trials, outperforms clinicians in predicting risk, and was qualified by the European Medicines Agency as an endpoint for clinical trials in 2022.

However, while the clinical value of the iBox and similar predictive tools is well documented, patient perceptions remain largely unexplored. Understanding how kidney transplant recipients perceive the prediction of their individual risk of graft loss (in terms of usefulness, acceptability, fears, or impact on their daily life), as well as their broader views on the role of artificial intelligence in medicine - including their hopes, expectations, and concerns about its deployment - is essential to ensure an ethical, transparent, and truly patient-centered implementation.

## Study period

January 2026: Distribution of the questionnaire to the collaborating transplant centers and patient associations. February 2026: Data collection and management. April 2026: Analysis of results. June 2026: Presentation and discussion of results with the various participating centers/associations. September 2026: Publication.

## Sample size

The questionnaire will be distributed to a sample of between 10,000 and 20,000 kidney transplant recipients. Based on response rates observed in comparable studies using patient questionnaires, an estimated response rate of 10% to 15% is expected, which would yield a sufficient volume of responses to ensure statistical robustness and diversity of represented profiles.

## Study type

Cross-sectional, international, and multicenter survey, conducted via an anonymized online questionnaire. The study adopts a mixed-methods approach, combining qualitative and quantitative analysis of responses. No medical or biological data will be used, nor will data collected during clinical care be reused.

  • Questionnaire development: The questionnaire was developed based on a review of the existing literature on patient perceptions of artificial intelligence and predictive medicine. An initial version of the questionnaire was developed and tested with four French patients. After adjustments, a bilingual translation was carried out by French-speaking and English-speaking collaborators. The final questionnaire was then shared with American patients for linguistic and cultural validation (questionnaire presented in the appendix of this document**).
  • Questionnaire distribution:** Distribution will be carried out through partner patient associations and collaborating transplant centers in France and the United States. The questionnaire will be distributed via a secure and anonymized REDCap platform, hosted on institutional servers compliant with data protection standards (GDPR). Participants will receive a unique link allowing them to access the online questionnaire directly. Participants will be able to respond at their own pace and discontinue their participation at any time without justification or consequence.
  • Data analysis:** The collected responses will be analyzed using a quantitative approach. Qualitative analyses will rely on thematic analysis assisted by large language models (LLMs). These models will automatically extract recurring themes, associated emotions, and nuances of perception in the free-text responses, using a standardized methodology developed by the investigators. This type of LLM-based thematic analysis was already successfully conducted in the investigators' group. To ensure reliability and scientific rigor, a systematic manual verification will be performed on a representative sub-sample of responses. This independent review will compare human and automated coding and refine the thematic categories.
  • Data collected
  • Age
  • Sex
  • Year of last transplant
  • Country of last transplant
  • Transplant follow-up center
  • Transplant rank
  • Current occupation or last occupation held
  • Perceptions of the role of AI in medicine
  • Perceptions regarding a graft loss risk prediction system
  • Data flow

Data will be collected via the REDCap platform (HDS-certified hosting, GDPR-compliant). The questionnaire is anonymous: no nominative or identifiable medical data will be collected. Each participant will receive a unique link generating an untraceable alphanumeric identifier. Data will be transferred from REDCap and stored in encrypted form on institutional servers. Access will be strictly limited to the project investigators (Marc Raynaud, Alexandre Loupy) and the data manager (Thibaut Thalamas) via secure authentication. Data analyses will be performed on an internal environment using R. Fully anonymized datasets may be archived for secondary research or scientific replicability purposes.

## Participant information

Participants will be contacted by email via their follow-up center, using contact databases already existing at these centers. The invitation message will briefly present the study and its sponsor, the Paris Institute for Transplantation and Organ Regeneration, as well as the responsible researchers. It will also contain an information notice outlining the study objectives, confidentiality procedures, and a direct link to the online questionnaire hosted on REDCap. Participation will be entirely voluntary, with no impact on medical follow-up or the relationship with the transplant team.

Keywords
artificial intelligence, survey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07600541
Study groupRoleWhat they receive
Vita moveAssociation of transplant recipients
France rein pays de la loireAssociation of patients with kidney disease
France rein île de franceAssociation of patients with kidney disease
France rein nord pas de calaisAssociation of patients with kidney disease
Saint-Louis hospitalHospital
Nice PasteurHospital
Marseille hospitalhospital
Lillehospital
The voice of the patientAssociation of patients with kidney disease
Utah universityhospital
Mayo Clinic jacksonvillehospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceptions of patients about AI

    Perceptions of kidney transplant recipients regarding the use of artificial intelligence, assessed with a questionnaire

    Measured: Baseline (corresponding to questionnaire administration)

Secondary outcomes (1)
  1. Perceptions of patients about the use of a graft failure prediction system

    This study aims to explore the perceptions of kidney transplant recipients regarding the use of a graft loss risk prediction system, assessed with a questionnaire

    Measured: Baseline (corresponding to questionnaire administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start15 Apr 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07600541
Sponsor's protocol ID
AI_patient
Acronym
AITX
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is part of the investigators' protocol: as these data will reflect the views of the patients, the investigators prefer to keep them confidential.

Publications

  • Young AT, Amara D, Bhattacharya A, Wei ML. Patient and general public attitudes towards clinical artificial intelligence: a mixed methods systematic review. Lancet Digit Health. 2021 Sep;3(9):e599-e611. doi: 10.1016/S2589-7500(21)00132-1.

    PubMed 34446266
  • https://osf.io/preprints/psyarxiv/pnx9e_v1

  • Fritsch SJ, Blankenheim A, Wahl A, Hetfeld P, Maassen O, Deffge S, Kunze J, Rossaint R, Riedel M, Marx G, Bickenbach J. Attitudes and perception of artificial intelligence in healthcare: A cross-sectional survey among patients. Digit Health. 2022 Aug 8;8:20552076221116772. doi: 10.1177/20552076221116772. eCollection 2022 Jan-Dec.

    PubMed 35983102
  • Erul E, Aktekin Y, Danisman FB, Gumustas SA, Aktekin BS, Yekeduz E, Urun Y. Perceptions, Attitudes, and Concerns on Artificial Intelligence Applications in Patients with Cancer. Cancer Control. 2025 Jan-Dec;32:10732748251343245. doi: 10.1177/10732748251343245. Epub 2025 May 23.

    PubMed 40407404
  • Divard G, Raynaud M, Tatapudi VS, Abdalla B, Bailly E, Assayag M, Binois Y, Cohen R, Zhang H, Ulloa C, Linhares K, Tedesco HS, Legendre C, Jouven X, Montgomery RA, Lefaucheur C, Aubert O, Loupy A. Comparison of artificial intelligence and human-based prediction and stratification of the risk of long-term kidney allograft failure. Commun Med (Lond). 2022 Nov 23;2(1):150. doi: 10.1038/s43856-022-00201-9.

    PubMed 36418380
  • Truchot A, Raynaud M, Helantera I, Aubert O, Kamar N, Divard G, Astor B, Legendre C, Hertig A, Buchler M, Crespo M, Akalin E, Pujol GS, Ribeiro de Castro MC, Matas AJ, Ulloa C, Jordan SC, Huang E, Juric I, Basic-Jukic N, Coemans M, Naesens M, Friedewald JJ, Silva HT Jr, Lefaucheur C, Segev DL, Collins GS, Loupy A. Competing and Noncompeting Risk Models for Predicting Kidney Allograft Failure. J Am Soc Nephrol. 2025 Apr 1;36(4):688-701. doi: 10.1681/ASN.0000000517. Epub 2024 Oct 16.

    PubMed 40168162
  • Lombardi Y, Raynaud M, Schatzl M, Mayer KA, Diebold M, Patel UD, Schrezenmeier E, Akifova A, Budde K, Loupy A, Bohmig GA. Estimating the efficacy of felzartamab to treat antibody-mediated rejection using the iBox prognostication system. Am J Transplant. 2025 May;25(5):1130-1132. doi: 10.1016/j.ajt.2024.12.004. Epub 2024 Dec 12. No abstract available.

    PubMed 39674514
  • Loupy A, Preka E, Chen X, Wang H, He J, Zhang K. Reshaping transplantation with AI, emerging technologies and xenotransplantation. Nat Med. 2025 Jul;31(7):2161-2173. doi: 10.1038/s41591-025-03801-9. Epub 2025 Jul 14.

    PubMed 40659768
  • Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly E, Buchler M, Ladriere M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Bohmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.

    PubMed 34756569
  • Hart A, Gustafson SK, Wey A, Salkowski N, Snyder JJ, Kasiske BL, Israni AK. The association between loss of Medicare, immunosuppressive medication use, and kidney transplant outcomes. Am J Transplant. 2019 Jul;19(7):1964-1971. doi: 10.1111/ajt.15293. Epub 2019 Mar 5.

    PubMed 30838768

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant, run by Paris Translational Research Center for Organ Transplantation at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceptions of patients about AI (time frame: Baseline (corresponding to questionnaire administration)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07600541, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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