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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474003
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Alexandre Loupy, Paris Translational Research Center for Organ Transplantation

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. 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.


Condition or disease Intervention/treatment
Kidney Transplantation Other: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 2002
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    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.


Primary Outcome Measures :
  1. Allograft survival probability [ Time Frame: Allograft survival probability at 7 year post transplantation ]
    Allograft survival probability, calculated from a composite score (based on clinical, histological, immunological, and functional variables) assessed at the time of biopsy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Combined transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474003


Contacts
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Contact: Alexandre Loupy, PhD 0033612491082 alexandreloupy@gmail.com

Locations
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United States, Maryland
Department of Surgery, Johns Hopkins University School of Medicine Enrolling by invitation
Baltimore, Maryland, United States, 21205
United States, Minnesota
William J. von Liebig Center for Transplantation and Clinical Regeneration Enrolling by invitation
Rochester, Minnesota, United States, 55905
United States, Virginia
Virginia Commonwealth University School of Medicine Enrolling by invitation
Richmond, Virginia, United States, 980663
Belgium
Department of Nephrology and Renal Transplantation, University Hospitals Leuven Enrolling by invitation
Leuven, Belgium, 3000
France
Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon Enrolling by invitation
Lyon, France, 69002
Centre Hospitalier Universitaire de Nantes Enrolling by invitation
Nantes, France, 44093
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France ; Recruiting
Paris, France, 75010
Contact: Carmen Lefaucheur, PhD       carmenlefaucheur4@gmail.com   
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France; Recruiting
Paris, France, 7509
Contact: Alexandre Loupy, PhD    0033612491082    alexandreloupy@gmail.com   
Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch, Suresnes, France Enrolling by invitation
Suresnes, France, 92150
Department of Nephrology and Organ Transplantation, CHU Rangueil Enrolling by invitation
Toulouse, France, 31059
Sponsors and Collaborators
Paris Translational Research Center for Organ Transplantation
Investigators
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Principal Investigator: Alexandre Loupy, PhD Paris Translational Research Center for Organ Transplantation
Principal Investigator: Carmen Lefaucheur, PhD Paris Translational Research Center for Organ Transplantation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Alexandre Loupy, Paris Translational Research Center for Organ Transplantation
ClinicalTrials.gov Identifier: NCT03474003    
Other Study ID Numbers: IBOX001
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Alexandre Loupy, Paris Translational Research Center for Organ Transplantation:
Score prediction
Allograft survival