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

NCT03474003 | Completed

• 1 other identifier: IBOX001
• Study Type: observational
• Target: 7,557
• Locations: 3 countries
• Sites: 10

Brief 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. 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. This project aims:

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

Conditions

Kidney Transplantation

Keywords

Score prediction; Allograft survival

Outcome Measures

Primary Outcomes (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.

  Allograft survival probability at 7 year post transplantation

Interventions

No intervention OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Combined transplantation

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (10)

Department of Surgery, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

William J. von Liebig Center for Transplantation and Clinical Regeneration

Rochester, Minnesota, 55905, United States

Location

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 980663, United States

Location

Department of Nephrology and Renal Transplantation, University Hospitals Leuven

Leuven, 3000, Belgium

Location

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

Lyon, 69002, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

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

Paris, 75010, France

Location

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

Paris, 7509, France

Location

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

Suresnes, 92150, France

Location

Department of Nephrology and Organ Transplantation, CHU Rangueil

Toulouse, 31059, France

Location

Related Publications (3)

• 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.

  PMID: 40168162 DERIVED

• 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.

  PMID: 34620664 DERIVED

• 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 DERIVED

Study Officials

• Alexandre Loupy, PhD

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

• Carmen Lefaucheur, PhD

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Alexandre Loupy

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 22, 2018
• Study Start: January 1, 2002
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); BE (1); US (3)