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

Kidney Transplantation Clinical Trial

— iBOX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474003
• Other study ID #: IBOX001
• Status: Completed
• Start date: January 2002
• Est. completion date: April 29, 2020

Study information

• Verified date: April 2020
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7557
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney recipient transplanted after 2002

• Kidney recipient over 18 years of age

Exclusion Criteria:

• Combined transplantation

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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.

Locations

Country	Name	City	State
Belgium	Department of Nephrology and Renal Transplantation, University Hospitals Leuven	Leuven
France	Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon	Lyon
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France;	Paris
France	Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France ;	Paris
France	Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch, Suresnes, France	Suresnes
France	Department of Nephrology and Organ Transplantation, CHU Rangueil	Toulouse
United States	Department of Surgery, Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Virginia Commonwealth University School of Medicine	Richmond	Virginia
United States	William J. von Liebig Center for Transplantation and Clinical Regeneration	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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