Human Versus Computer-based Predictions of Long Allograft Survival

NCT04918199 | Completed

• 1 other identifier: iBoxvsHuman
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplant Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the parameters' importance in the prediction for physicians

  7 years

• Inter-rater agreement

  7 years

Study Arms (1)

Paris Transplant Group cohort

400 (10%) of the patients were randomly selected from 4,000 consecutive patients over 18 years of age prospectively enrolled at the time of kidney transplantation from a living or deceased donor at Necker Hospital, Saint-Louis Hospital, Foch Hospital, and Toulouse Hospital between January 1, 2005, and January 1, 2014, in France.

Device: Computer based assessment (iBox); Other: Physician assessement

Interventions

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.

Paris Transplant Group cohort

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,

Paris Transplant Group cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

400 (10%) of the patients were randomly selected with an evaluation available at one-year post-transplant from the Paris Transplant Group cohort, which gathers 4,000 consecutive patients over 18 years of age prospectively enrolled at the time of kidney transplantation from a living or deceased donor at Necker Hospital, Saint-Louis Hospital, Foch Hospital, and Toulouse Hospital between January 1, 2005, and January 1, 2014, in France.

You may qualify if:

• transplant evaluation available at one year post-transplant

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (1)

Paris Translational Centre for Organ Transplantation

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

Location

Related 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.

  PMID: 31530561 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: March 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)