Assesment the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients" — AI-CARE  

Renal Transplantation Clinical Trial

Official title: Randomized Controlled Multicenter Trial to Sassess the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"

Status Not yet recruiting

Clinical Trial 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, biopsies are guided by dd-cfDNA at the same timepoints

Clinical Trial Description

The main objective of this study is to demonstrate the ability of dd-cfDNA levels in the blood combined with clinical data to decrease the number of allograft biopsies during the first 18 months after transplantation.

500 new transplanted patients in 5 Frenchclinical transplant sites will be included in the prospective multicenter AI-CARE trial. Recruitment of patients will start on the day of transplantation (or 8 days before for transplantations with living donor) and data/samples collected at 3 months and 12 months after transplantation and during visits for clinical indication within the first 18 months of follow-up. Realization of all the acts for the research are representing the usual medical practice (Standard Of Care: SOC) except one additional blood sample for dd-cfDNA analyses that will be collected and analyzed specifically for the research. The paraffin-embedded core dedicated to SOC histology will be used for gene expression profiling and digital pathology imaging after SOC procedures.

Using the newest information derived from dd-cfDNA analyses combined with clinical data, dd-cfDNA will allow us to identify kidney transplant patients at low- and high-risk of rejection.

using non-invasive dd-cfDNA levels combined with clinical data, preventing unnecessary allograft biopsies which are invasive, with and present a potential risk of complications for the patients and costly burden to the healthcare vasive, with a potential risk of complications for the patients and costly to the healthcare system. ;

Related Conditions & MeSH terms

• Renal Transplantation

• NCT number: NCT06406179
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lefaucheur, Carmen, PR
• Phone: +33676604946
• Email: carmenlefaucheur4@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: June 1, 2027