Evaluating cell-free DNA in kidney transplant patients
Official title: Study of the Evolution of Circulating Plasma and Urinary DNA of Renal Origin in Kidney Transplant Patients
Run by CGenetix · NCT06910527 · Data updated 2026-11-12
This study is testing a new method to see if analyzing DNA in blood and urine can help doctors detect kidney transplant rejection earlier in patients who are having a biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | CGenetix Industry-sponsored |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | May 30, 2024 |
| Main results expected | May 31, 2025 |
| Study ends | May 31, 2026 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06910527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are kidney transplant patients who are admitted for suspected transplant rejection requiring a renal biopsy.
✕Probably not a fit
Patients with cognitive or mental disorders that prevent them from consenting, or those who refuse participation, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the sensitivity of a new diagnostic technology developed by CGenetix for detecting circulating renal DNA in kidney transplant patients. The study focuses on patients who are suspected of experiencing transplant rejection and are scheduled for a renal biopsy. By analyzing plasma and urinary cell-free DNA, the researchers hope to identify the tissue origin of the DNA and improve early detection of graft rejection. The study involves obtaining blood samples and patient consent during routine monitoring and biopsy procedures.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of kidney transplant rejection, potentially enhancing patient outcomes.
How similar studies have gone: While the approach of using cell-free DNA for monitoring transplant rejection is gaining interest, this specific methodology is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients living with a kidney transplant * Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication Exclusion Criteria: * 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
Where it's running
-
Chu Rouen-Bois Guillaume
Rouen, France Recruiting
Study contacts
- Principal investigator: Tristan de Nattes, Medical Doctor — Chu Rouen University
- Study coordinator: GEOFFROY GP POULET, PhD
- Email: geoffroy.poulet@cgenetix.com
- Phone: +33667772394
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Finding the right steroid dose for acute T cell rejection after kidney or kidney–pancreas transplant
This trial will test whether lower doses of steroids work as well as higher doses to treat acute T cell–mediated rejection in people who have had a kidney or simultaneous kidney–pancreas transplant.
-
Understanding rejection in uterine transplantation
This study is trying to understand why some uterine transplants are rejected by the body and find easier ways to check for rejection in patients who have received or donated a uterus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.