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

May 13, 2026 updated by: Marc Raynaud, Paris Translational Research Center for Organ Transplantation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Nice Pasteur
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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%

Description

  • Inclusion criteria

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

  • Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Vita move
Association of transplant recipients
France rein pays de la loire
Association of patients with kidney disease
France rein île de france
Association of patients with kidney disease
France rein nord pas de calais
Association of patients with kidney disease
Saint-Louis hospital
Hospital
Nice Pasteur
Hospital
Marseille hospital
hospital
Lille
hospital
The voice of the patient
Association of patients with kidney disease
Utah university
hospital
Mayo Clinic jacksonville
hospital

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceptions of patients about AI
Time Frame: Baseline (corresponding to questionnaire administration)
Perceptions of kidney transplant recipients regarding the use of artificial intelligence, assessed with a questionnaire
Baseline (corresponding to questionnaire administration)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceptions of patients about the use of a graft failure prediction system
Time Frame: Baseline (corresponding to questionnaire administration)
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
Baseline (corresponding to questionnaire administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paris Translational Research Center for Organ Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI_patient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is part of the investigators' protocol: as these data will reflect the views of the patients, the investigators prefer to keep them confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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