MedTrace Logo

Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients

NCT07805343 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-09-04

No results posted yet for this study

Summary

This is a multinational, multi-center, observational cohort study.

Kidney allograft rejection is poorly detected by standard-of-care biomarkers. Although dd-cfDNA has been associated with improved rejection detection when added to standard-of-care biomarkers and clinical parameters, little is known about its performance across Banff 2022 rejection phenotypes and injury patterns, in various clinical scenarios and populations, and when measured repeatedly over time.

Conditions

  • Rejection Acute Renal
  • Rejection Chronic Renal
  • Transplantation
  • Kidney Rejection Transplant

Interventions

DIAGNOSTIC_TEST

Donor-derived cell-free DNA

Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.

Sponsors & Collaborators

  • Fondation pour la Recherche Médicale

    collaborator OTHER

  • Université Paris Cité

    collaborator OTHER

  • Paris Cardiovascular Research Center (Inserm U970)

    collaborator OTHER_GOV

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Germany
  • South Korea
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT07805343 on ClinicalTrials.gov