Detecting kidney DNA in transplant patients with potential rejection
Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection
This study is testing a new way to check for kidney transplant rejection by looking at DNA in the blood of patients instead of doing a traditional biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 319 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06351488 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and characterize kidney transplant rejection by analyzing circulating DNA in the blood of patients facing graft rejection episodes. It leverages the epigenetic properties of circulating DNA to provide a non-invasive diagnostic alternative to traditional biopsy methods. The study involves patients who are scheduled for a kidney biopsy at specific hospitals in Paris and seeks to improve the understanding of graft dysfunction through innovative diagnostic techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have at least one functioning kidney graft and are scheduled for a biopsy.
Not a fit: Patients under legal protection measures or those without a functioning kidney graft will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and less invasive detection of kidney transplant rejection, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using circulating DNA for diagnostic purposes, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 ans * Patient living with at least one functioning kidney graft * Summoned to perform a kidney biopsy for cause/indication at the Pitié Salpêtrière Hospital or at the Necker Hospital * Having been informed of the study and not opposing the study * Benefiting from a social security system (excluding AME) Exclusion Criteria: * Under legal protection measure (curatorship or guardianship, under judicial protection).
Where this trial is running
Paris and 2 other locations
- Assistance Publique - Hôpitaux de Paris, Hôpital Necker — Paris, France (Recruiting)
- Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière hospital — Paris, France (Active_not_recruiting)
- Assistance Publique - Hôpitaux de Paris, Hôpital Tenon — Paris, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Pierre GALICHON, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Pierre GALICHON, Pr
- Email: pierre.galichon@aphp.fr
- Phone: 1 42 17 72 29
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.