Human Versus Computer-based Predictions of Long Allograft Survival

Kidney Transplant Failure Clinical Trial

— iBox vs Human  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918199
• Other study ID #: iBoxvsHuman
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• transplant evaluation available at one year post-transplant

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Kidney Transplant Failure

Intervention

Device:
• Computer 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.

Other:
• Physician 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,

Locations

Country	Name	City	State
France	Paris Translational Centre for Organ Transplantation	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation

Country where clinical trial is conducted

France, 

References & Publications (1)

Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Bohmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death censored allograft failure seven years after risk assessment	Predictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment.	7 years
Secondary	Evaluation of the parameters' importance in the prediction for physicians	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.	7 years
Secondary	Inter-rater agreement	Fleiss kappa will be used to measure inter-rater agreement between each physician's ranking	7 years