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Kidney TransplantationiBOXNCT03474003

Development and Validation of a Multidimensional Score to Predict Long-term Kidney Transplant Outcomes

An observational study of Kidney Transplantation, run by Paris Translational Research Center for Organ Transplantation at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
How many people
7,557 participants
Where
10 sitesin 3 countries
Study dates
Jan 2002to 29 Apr 2020
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
  • Adult, Older adult

Study population: Kidney recipients aged over 18 and of all sexes recruited from 2002 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies for allograft survival assessment as well as RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.

Who may be able to join

  • Kidney recipient transplanted after 2002
  • Kidney recipient over 18 years of age

Who cannot join

  • Combined transplantation

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

France6 sites

  • Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon

    Lyon, 69002

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France ;

    Paris, 75010

  • Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France;

    Paris, 7509

  • Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch, Suresnes, France

    Suresnes, 92150

  • Department of Nephrology and Organ Transplantation, CHU Rangueil

    Toulouse, 31059

Other trials in France

United States3 sites

  • Department of Surgery, Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia, 980663

  • William J. von Liebig Center for Transplantation and Clinical Regeneration

    Rochester, Minnesota, 55905

Other trials in United States

Belgium1 site

  • Department of Nephrology and Renal Transplantation, University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: Multicenter International Observational Study to Build and Validate Multidimensional Risk Score in the Clinical Setting of Kidney Allograft Biopsies to Predict Long-term Allograft Survival

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making.

Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles.

Read more

This project aims:

  1. To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation;
  2. To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients;

Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

Read the detailed description

Background The field of kidney transplantation currently lacks robust models to predict long-term allograft failure, which represents a major unmet need in clinical care and clinical trials. This study aims to generate and validate an accessible scoring system that predicts individual patients' risk of long-term kidney allograft failure.

Main Outcome(s) and Measure(s)

A score based on classical statistical approaches to model determinants of allograft and patient survival (Cox model, multinomial regression). These models will be further completed with statistical approaches derived from artificial intelligence and machine learning.

Being tested
No intervention
Keywords
Score prediction, Allograft survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    Kidney recipients aged over 18 and of all sexes recruited from 2002 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; RCT conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Allograft survival probability

    Allograft survival probability, calculated from a composite score (based on clinical, histological, immunological, and functional variables) assessed at the time of biopsy.

    Measured: Allograft survival probability at 7 year post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study startJan 2002
  3. Primary completion29 Apr 2020
  4. Study completion29 Apr 2020

Resources

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
Prospective
Enrolment
7,557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474003
Sponsor's protocol ID
IBOX001
Acronym
iBOX
Status last verified
Apr 2020
First submitted
6 Mar 2018
Last updated
1 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Truchot A, Raynaud M, Helantera I, Aubert O, Kamar N, Divard G, Astor B, Legendre C, Hertig A, Buchler M, Crespo M, Akalin E, Pujol GS, Ribeiro de Castro MC, Matas AJ, Ulloa C, Jordan SC, Huang E, Juric I, Basic-Jukic N, Coemans M, Naesens M, Friedewald JJ, Silva HT Jr, Lefaucheur C, Segev DL, Collins GS, Loupy A. Competing and Noncompeting Risk Models for Predicting Kidney Allograft Failure. J Am Soc Nephrol. 2025 Apr 1;36(4):688-701. doi: 10.1681/ASN.0000000517. Epub 2024 Oct 16.

    PubMed 40168162

  • Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.

    PubMed 34620664

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation, run by Paris Translational Research Center for Organ Transplantation at 10 sites in 3 countries.

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 2 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, United States, Belgium. 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?

Allograft survival probability (time frame: Allograft survival probability at 7 year post transplantation). 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 NCT03474003, which also lists 3 linked publications.

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 1 May 2020.

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