Actively Recruiting
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-24
30
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new way to monitor kidney transplant rejection and dysfunction by measuring specific epigenetic markers in donor-derived cell-free DNA found in the blood. This approach aims to improve upon current methods, which rely on non-specific markers like serum creatinine and invasive kidney biopsies. The study focuses on distinguishing kidney DNA signals from the patient's original kidney versus the transplanted kidney, especially in patients with chronic kidney disease undergoing transplantation. The study involves collecting blood samples from patients before and after kidney transplantation to measure renal-specific cell-free DNA using a patented multiplex digital-PCR assay. Researchers will also analyze graft perfusion fluid to validate these markers and study tissue damage during organ transport. This observational study does not involve treatment but focuses on evaluating the evolution and characteristics of kidney-derived DNA markers. Participants will provide blood samples at specific times: about 6 hours before transplantation and 12 to 24 hours after surgery, with additional assessments 7 days post-transplant. The study measures include the amount of renal circulating cell-free DNA and the variability of these markers between individuals, as well as their association with graft function recovery. The study also monitors the presence of epigenetic signatures related to acute kidney injury and tracks graft performance over time.
CONDITIONS
Brief Title
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with end-stage renal failure
- Scheduled for a kidney transplant at Pitié Salpêtrière Hospital
- Provided free and informed written consent for genetic analysis
- Covered by a social security scheme (excluding AME)
You will not qualify if you...
- Under legal protective measures such as curatorship, guardianship, or judicial safeguard
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 - 1 day
Participants provide blood samples before and after kidney transplant surgery to analyze kidney-specific circulating DNA markers.
2 visits (1 before transplant and 1 within 24 hours after transplant, in-person)
Duration - 7 days
Participants are monitored to study the association between circulating DNA markers and graft function recovery after transplantation.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Pitié-Salpétriêre Hospital
Paris, Île-de-France Region, France, 75013
Actively Recruiting
Research Team
S
Sarah Dr DROUIN, MD-PhD
G
Geoffroy Dr POULET, PhD
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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