Actively Recruiting
Randomized Controlled Trial Evaluating Donor-Derived Cell-Free DNA in Routine Care of Kidney Transplant Recipients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-05
500
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether using donor-derived cell-free DNA (dd-cfDNA) as a marker combined with clinical data can reduce the number of invasive kidney biopsies needed to monitor rejection in kidney transplant patients. This multicenter, randomized trial involves clinically stable kidney transplant recipients and aims to improve follow-up care by identifying patients at low or high risk of rejection more safely and efficiently than current methods. Participants are divided into two groups: one receives standard follow-up with scheduled biopsies at 3 and 12 months post-transplant and additional biopsies if clinically indicated, while the other group receives the same follow-up but with added dd-cfDNA testing results to guide biopsy decisions. Blood samples for dd-cfDNA are taken at baseline, 3 months, 12 months, and during clinical visits up to 18 months post-transplant. Biopsy decisions in the dd-cfDNA-guided group are informed by risk reports but ultimately made by physicians. Participants will attend up to five clinical indication visits within 18 months after transplant, during which medical data and dd-cfDNA results are collected. Researchers will assess kidney function using estimated glomerular filtration rate (eGFR), monitor graft survival, track biopsy-proven rejection, and measure gene expression profiles from biopsy tissue. Patient-reported outcomes, healthcare costs, and anxiety levels will also be evaluated throughout the study. The total participation duration is 18 months from transplantation.
CONDITIONS
Brief Title
Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Recipient of a kidney transplant from a deceased or living donor
- Includes retransplantation after graft loss or rejection
- Willing and able to provide signed informed consent
- Women of childbearing potential must use effective contraception during the study
You will not qualify if you...
- Legally detained individuals or those under legal protection
- Any condition that the investigator believes could interfere with participation or increase risk
- History of multi-organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 8 days before transplantation or on the day of transplantation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 18 months
Participants undergo kidney transplantation and follow either standard clinical follow-up or a dd-cfDNA-guided strategy to monitor transplant rejection risk. Blood samples for dd-cfDNA analysis are taken at transplantation, 3 months, 12 months, and up to 5 additional clinical indication visits within the first 18 months. Biopsies may be performed based on clinical indication and dd-cfDNA risk stratification.
Visits at transplantation, 3 months, 12 months, and up to 5 additional clinical indication visits
Trial Site Locations
Total: 6 locations
1
Georges Pompidou European Hospital
Paris, France, 75015
Active, Not Recruiting
2
Hôpital Necker-Enfants Malades
Paris, France, 75015
Active, Not Recruiting
3
AP-HP - Hôpital Tenon
Paris, France
Active, Not Recruiting
4
CHU Toulouse
Toulouse, France
Not Yet Recruiting
5
Hopital Saint Louis
Paris, Île-de-France Region, France, 75010
Actively Recruiting
6
Hôpital de la Salpêtrière hôpital à Paris
Paris, Île-de-France Region, France, 75013
Actively Recruiting
Research Team
L
Lefaucheur, Carmen, PR
R
Racape Maud, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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