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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06406179 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tr

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📋 Eligibility rules (as published)
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).
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What it tests

  • dd-cfDNA-guided
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Where

6 sites
Georges Pompidou European Hospital
Paris, France
Hôpital Necker-Enfants Malades
Paris, France
AP-HP - Hôpital Tenon
Paris, France
CHU Toulouse
Toulouse, France
Hopital Saint Louis
Paris, France
Hôpital de la Salpêtrière hôpital à Paris
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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