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NCT03474003 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Paris Translational Research Center for Organ Transplantation.

Completed
Registry status
7,557
Enrollment target

NCT03474003: Completed study, sponsored by Paris Translational Research Center for Organ Transplantation.

NCT03474003 is a clinical trial that has completed, run by Paris Translational Research Center for Organ Transplantation. The registered enrollment target is 7,557 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03474003 has completed, sponsored by Paris Translational Research Center for Organ Transplantation.

COMPLETED
Registry status
7,557 participants
Enrollment target

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.

Primary Outcome

Allograft survival probability, calculated from a composite score (based on clinical, histological, immunological, and functional variables) assessed at the time of biopsy.

Interventions

  • OTHER No intervention

Trial Details

FieldValue
Enrollment Target 7,557 participants
Start Date 2002-01
Est. Completion 2020-04-29

What the finished NCT03474003 record still lists

NCT03474003 is an observational study that tracks outcomes without assigning an intervention. Its 7,557 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.

NCT03474003 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03474003 about?

NCT03474003 is a clinical study titled "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 populati...

What is the current status of trial NCT03474003?

This trial is currently completed. The enrollment target is 7,557 participants. The study started on 2002-01. Estimated completion is 2020-04-29.

What interventions are being tested in trial NCT03474003?

The interventions under investigation include: No intervention (OTHER).

Who is sponsoring clinical trial NCT03474003?

This trial is sponsored by Paris Translational Research Center for Organ Transplantation, which has 7 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03474003, the US trial registry maintained by the National Library of Medicine. NCT03474003 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.