Actively Recruiting
Detection of Circulating Kidney DNA to Diagnose Graft Rejection in Kidney Transplant Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-19
319
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
C
CGenetix
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on patients who have received kidney transplants and are at risk of graft rejection, a condition affecting nearly 30% of transplant recipients despite regular medical follow-up. The study aims to evaluate a new non-invasive method to diagnose antibody-mediated kidney transplant rejection using epigenetic biomarkers found in circulating DNA from blood and urine. This approach is being developed in partnership with CGenetix and INSERM units to improve early detection and classification of rejection types based on kidney tissue origin, compared to the current gold standard of kidney biopsy with Banff 2022 classification. Participants in this observational study will be recruited at the time they are hospitalized for a kidney biopsy due to suspected graft rejection. Blood and urine samples will be collected within 24 hours before the biopsy to measure circulating kidney DNA using digital PCR. The study will analyze various kidney-specific DNA markers and urinary chemokines to assess their ability to predict different types of rejection, including antibody-mediated, T-cell mediated, mixed, and others. The research aims to validate a diagnostic test that could provide a less invasive alternative to biopsy. Throughout the study, researchers will monitor the levels of circulating kidney DNA and urinary chemokines, comparing these biomarkers to biopsy findings. The main outcome is the performance of these biomarkers in predicting antibody-mediated rejection, measured by the area under the ROC curve at the time of biopsy. Secondary outcomes include prediction of other rejection types and specific kidney tissue involvement. The study will enroll 319 patients and involves sample collection at the time of biopsy. Participation continues with routine care and monitoring of transplant health over time.
CONDITIONS
Brief Title
Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Living with at least one functioning kidney transplant
- Scheduled for a kidney biopsy for cause or indication at Pitié Salpêtrière or Necker Hospital
- Informed about the study and not opposed to participation
- Covered by a social security system (excluding AME)
You will not qualify if you...
- Under a legal protection measure such as curatorship, guardianship, or judicial protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 day before biopsy
Participants scheduled for a kidney biopsy provide urine and blood samples within 24 hours before the biopsy to measure circulating kidney DNA and urinary chemokines for non-invasive diagnosis of graft rejection.
1 visit (in-person)
Duration - Up to study completion in 2026
Participants are observed over time to evaluate graft function and rejection status based on biopsy and biomarker results without active intervention.
Visit schedule as per routine clinical follow-up
Trial Site Locations
Total: 3 locations
1
Assistance Publique - Hôpitaux de Paris, Hôpital Necker
Paris, France, 75013
Actively Recruiting
2
Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière hospital
Paris, France, 75013
Active, Not Recruiting
3
Assistance Publique - Hôpitaux de Paris, Hôpital Tenon
Paris, France, 75020
Not Yet Recruiting
Research Team
P
Pierre GALICHON, Pr
A
Anne BISSERY
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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