Actively Recruiting

Age: 18Years +
All Genders
NCT06910527

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

Led by Poulet Geoffroy · Updated on 2025-04-04

250

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

P

Poulet Geoffroy

Lead Sponsor

U

University Hospital, Rouen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients living with a kidney transplant
  • Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication
Not Eligible

You will not qualify if you...

  • Patients with cognitive and mental disorders rendering them unable to express their non-opposition to participation in the study
  • Not covered by a social security system
  • Under guardianship or legal protection
  • Patients who have expressed their refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu Rouen-Bois Guillaume

Rouen, France, 76230

Actively Recruiting

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Research Team

G

GEOFFROY GP POULET, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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