Kidney Transplant FailureiBox vs HumanNCT04918199
Human Versus Computer-based Predictions of Long Allograft Survival
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure
- What is being tested?
- Computer based assessment (iBox) and Physician assessement
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- transplant evaluation available at one year post-transplant
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
France1 site
Paris Translational Centre for Organ Transplantation
Paris, Île-de-France Region, 75015
About this study
Official title: Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification
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).
Read the 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.
- Conditions
- Kidney Transplant Failure
- Being tested
- Computer based assessment (iBox), Physician assessement
- Keywords
- iBox, individual risk prediction, kidney transplantation, long-term allograft outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 assessementOther
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Computer based assessment (iBox); Other: Physician assessement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 years
Secondary outcomes (2)
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.
Measured: 7 years
Inter-rater agreement
Fleiss kappa will be used to measure inter-rater agreement between each physician's ranking
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Mar 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918199
- Sponsor's protocol ID
- iBoxvsHuman
- Acronym
- iBox vs Human
- Status last verified
- Mar 2023
- First submitted
- 2 Jun 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31530561
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification
- ClinicalTrials.gov ID
- NCT04918199
- Acronym / sponsor ID
- iBox vs Human / iBoxvsHuman
- Conditions
- Kidney Transplant Failure
- Keywords
- iBox, individual risk prediction, kidney transplantation, long-term allograft outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paris Transplant Group cohort | – | Device: Computer based assessment (iBox), Other: Physician assessement400 (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- transplant evaluation available at one year post-transplant
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Paris Transplant Group cohort |
| Physician assessementBased on anonymized electronic health records, physicians have to determine a percentage of death censored allograft survival seven years after the time of risk evaluation, | Other | Paris Transplant Group cohort |
Primary outcome
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.
2 secondary outcomes
Evaluation of the parameters' importance in the prediction for physicians
Time frame: 7 years
Inter-rater agreement
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 31530561Loupy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death censored allograft failure seven years after risk assessment (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.