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Human Versus Computer-based Predictions of Long Allograft Survival

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04918199
Acronym
iBox vs Human
Enrollment
400
Registered
2021-06-08
Start date
2018-03-01
Completion date
2021-12-31
Last updated
2023-03-28

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

Conditions

Kidney Transplant Failure

Keywords

iBox, individual risk prediction, kidney transplantation, long-term allograft outcome

Brief summary

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).

Detailed description

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.

Interventions

DEVICEComputer based assessment (iBox)

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.

OTHERPhysician assessement

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,

Sponsors

Paris Translational Research Center for Organ Transplantation
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

* transplant evaluation available at one year post-transplant

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Death censored allograft failure seven years after risk assessment7 yearsPredictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment.

Secondary

MeasureTime frameDescription
Evaluation of the parameters' importance in the prediction for physicians7 yearsMean 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.
Inter-rater agreement7 yearsFleiss kappa will be used to measure inter-rater agreement between each physician's ranking

Countries

France

Outcome results

None listed

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