Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"

Recruiting now · Not applicable

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID

NCT06406179

Run by

Assistance Publique - Hôpitaux de Paris

People needed

500

Starts

2025-05-31

Expected to finish

2028-11-30

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Hopital Saint Louis — Paris, Île-de-France Region, France (enrolling)
• Hôpital de la Salpêtrière hôpital à Paris — Paris, Île-de-France Region, France (enrolling)
• Georges Pompidou European Hospital — Paris, France
• Hôpital Necker-Enfants Malades — Paris, France
• AP-HP - Hôpital Tenon — Paris, France
• CHU Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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