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

NCT03474003 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7557

Last updated 2020-05-01

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation

Interventions

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.

Sponsors & Collaborators

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Principal Investigators

  • Alexandre Loupy, PhD · Paris Translational Research Center for Organ Transplantation

  • Carmen Lefaucheur, PhD · Paris Translational Research Center for Organ Transplantation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2020-04-29
Completion
2020-04-29

Countries

  • United States
  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474003 on ClinicalTrials.gov