Condition: Renal Transplantation · Sponsor: Assistance Publique - Hôpitaux de Paris
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.
This description comes directly from the study's public registry record.
Lefaucheur, Carmen, PR · +33676604946 · carmenlefaucheur4@gmail.com
Racape Maud, PHD · +33 7 50 92 26 57 · maud.racape@inserm.fr
Always discuss trial participation with your own doctor first.
| Georges Pompidou European Hospital | Paris, France | Active Not Recruiting |
| Hôpital Necker-Enfants Malades | Paris, France | Active Not Recruiting |
| AP-HP - Hôpital Tenon | Paris, France | Active Not Recruiting |
| CHU Toulouse | Toulouse, France | Not Yet Recruiting |
| Hopital Saint Louis | Paris, Île-de-France Region, France | Recruiting |
| Hôpital de la Salpêtrière hôpital à Paris | Paris, Île-de-France Region, France | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06406179