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

Completed

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT03474003

Run by

Paris Translational Research Center for Organ Transplantation

People needed

7557

Starts

2002-01-01

Expected to finish

2020-04-29

Last updated by the study team

2020-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Combined transplantation

Where it is running

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

Full record on ClinicalTrials.gov

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