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

NCT06910527 | Recruiting

• 1 other identifier: PLAKID-TRANSP
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kidney transplantation; Cell-free DNA; Epigenetic

Outcome Measures

Primary Outcomes (1)

• Renal cell-free DNA in plasma and urine

  Quantification of Renal-cell-free DNA in plasma and urine exprimed in copy / mL of biological fluid

  24 Hours

Study Arms (1)

Kidney transplant patient eligible to a kidney biopsy

Kidney transplant patient eligible to a kidney biopsy (protocol and indication biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living with a kidney transplant eligible for a protocol biopsy or indication for suspected graft rejection

You may qualify if:

• Patients living with a kidney transplant
• Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication

You may not qualify if:

• 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 guardianship, or under legal protection.
• Patients who have expressed their refusal to participate in the study

Sponsors & Collaborators

• Poulet Geoffroy: lead
• University Hospital, Rouen: collaborator

Study Sites (1)

Chu Rouen-Bois Guillaume

Rouen, 76230, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and urine sample

Study Officials

• Geoffroy GP POULET, PhD

  CGenetix

  STUDY DIRECTOR

• TRISTAN DE NATTES, MEDICAL DOCTOR

  CHU ROUEN UNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GEOFFROY GP POULET, PhD

CONTACT

+33667772394; geoffroy.poulet@cgenetix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 4, 2025
• Study Start: May 30, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)