Skip to main content
OpenTrials
Completed

NCT Number: NCT03474003

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Combined transplantation

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Official study 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

Acronym: iBOX

Important dates

Study start
2002
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2018
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.