Evaluating cell-free DNA in kidney transplant patients
Study of the Evolution of Circulating Plasma and Urinary DNA of Renal Origin in Kidney Transplant Patients
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CGenetix Industry-sponsored |
| Locations | 1 site (Rouen) |
| Trial ID | NCT06910527 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant patients who are admitted for suspected transplant rejection requiring a renal biopsy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rouen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.