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Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients

NCT06910527 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-04-04

No results posted yet for this study

Summary

It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for early identification of transplant rejection, but not for characterization, i.e., identification of the affected renal fraction of the graft.

Recently, in healthy subjects, teams have shown that it is possible to identify the tissue origin of donor-cell-free DNA, based on the epigenetic properties of circulating DNA.

CGenetix is a MedTech company developing an in vitro diagnostic medical device to identify and quantify kidney graft degradation during transplant rejection. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating renal DNA released into the blood and urine in kidney transplant patients with or without graft rejection.

Conditions

  • Transplant Rejection
  • Transplant Kidney

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER

  • Poulet Geoffroy

    lead INDUSTRY

Principal Investigators

  • Geoffroy GP POULET, PhD · CGenetix

  • TRISTAN DE NATTES, MEDICAL DOCTOR · CHU ROUEN UNIVERSITY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • 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 NCT06910527 on ClinicalTrials.gov