NCT06406179 Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
| NCT ID | NCT06406179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Renal Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-05-31 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-05-31 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator hypothesizes that the combined use of (1) Donor-derived cell-free DNA (dd-cfDNA) in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive biopsy and less induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. In addition, the evaluation of the transcriptional changes in tissue samples in selected patients using automated processing of digital slide images and intragraft gene expression profiles will provide a better diagnosis of the rejection mechanisms to provide the best therapeutic approach as compared to current clinical practice. We therefore propose a French, multicenter, prospective randomized trial comparing two strategies of follow-up: in the first group, a biopsy is performed at M3, M12 and for clinical indication whenever considered necessary by the clinician during the first 18 months of follow-up after transplant. In the second group, patients will have the same follow-up as in the first group, but reports providing dd-cfDNA results and relevant medical parameters will be provided to the physician to help him in the decision to perform a biopsy or not.
Eligibility Criteria
Inclusion Criteria: * All men and women, age ≥18 years old. * Subject must be a recipient of a non-combined renal transplant from a deceased or living donor. It can be a re transplantation after a graft loss of function or graft rejection * Subject is willing and able to provide signed written informed consent and willing to comply with study procedures * Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: * Subjects who are legally detained in an official institution or under legal protection * Any condition that, in the opinion of the investigator, might interfere with the patient 's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient * History of multi-organ transplant (interference with rejection natural history).
Contact & Investigator
Alexandre Loupy, PR
STUDY DIRECTOR
APHP
Frequently Asked Questions
Who can join the NCT06406179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06406179 currently recruiting?
Yes, NCT06406179 is actively recruiting participants. Contact the research team at carmenlefaucheur4@gmail.com for enrollment information.
Where is the NCT06406179 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France, Toulouse, France and 2 additional locations.
Who is sponsoring the NCT06406179 clinical trial?
NCT06406179 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Alexandre Loupy, PR at APHP. The trial plans to enroll 500 participants.