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OpenTrials
Completed

NCT Number: NCT04918199

Human Versus Computer-based Predictions of Long Allograft Survival

The clinical decision-making after kidney transplantation is mainly driven by patient individual assessment. However, this task remains difficult and uncertain due to the integration of complex and numerous parameters. We aim to evaluate and compare the ability of transplant physicians to predict long term allograft survival compared with a computer-based survival prediction algorithm (iBox system).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Translational Centre for Organ Transplantation

Paris, Île-de-France Region, 75015, France

About this study

400 kidney transplant recipients among the cohort of 4,000 patients from the Paris Transplant Group prospective kidney transplant cohort (NCT03474003) were randomly selected. We generated an anonymized electronic health record for each included patient including a total of 60 classical kidney transplant prognostic parameters comprising baseline transplant and recipient characteristics, together with post-transplant parameters including allograft function, proteinuria, histology, diagnoses, and immunological profile collected during the first-year post-transplant. The time of risk evaluation for the human and the iBox system were at 1-year post transplant and the death censored allograft survival predictions made at 7 years after risk assessment. We enrolled transplant physicians at various stages of their careers (residents, fellows and seniors) to assign death censored graft survival probabilities at 7 years post risk assessment. The physicians were blinded to the actual patient outcome (allograft failure) and the iBox predictions. The physicians-based predictions will then be compared with the iBox system, a validated computer-based kidney survival prediction system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • transplant evaluation available at one year post-transplant

Exclusion criteria

  • no

Treatment and study plan

Computer based assessment (iBox)

Device

Individual allograft survival probabilities of death censored allograft survival seven years after the time of risk evaluation, computed using the iBox (NCT03474003), a qualified prognostication system designed to predict long term allograft survival up to seven years after evaluation.

Physician assessement

Other

Based on anonymized electronic health records, physicians have to determine a percentage of death censored allograft survival seven years after the time of risk evaluation,

Primary outcomes

  1. Death censored allograft failure seven years after risk assessment

    Time frame: 7 years

    Predictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment.

Secondary outcomes

  1. Evaluation of the parameters' importance in the prediction for physicians

    Time frame: 7 years

    Mean decrease in accuracy from a random survival forest from each physician will be used to determine the relative importance of the first ten parameters that led to their predictions.

  2. Inter-rater agreement

    Time frame: 7 years

    Fleiss kappa will be used to measure inter-rater agreement between each physician's ranking

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Official study title

Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification

Acronym: iBox vs Human

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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