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Non-Invasive Biomarker Strategy Integrating Dd-cfDNA Versus Biopsy-Based Monitoring in Kidney Transplant Recipients
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The investigator hypothesizes that the combined use of 1. non-invasive biomarkers including dd-cfDNA in peripheral blood predicting anti-donor immunological activation or quiescence with 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 biopsies to assess allograft rejection. It is therefore proposed a European, multicenter, prospective randomized trial comparing two strategies of follow-up: in the first, M3 biopsy decision is guided by a non-invasive, integrative dd-cfDNA-based decision support system, in the second one, a routine biopsy is performed at M3. In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician
Official title: Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
342
Start Date
2021-12-15
Completion Date
2024-05-28
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
biomarker-guided strategy
Patients will follow a biomarker-guided strategy including dd-cfDNA integrating with other biological and clinical parameters (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) to inform the decision on performing the M3 biopsy
Locations (8)
Nantes Hospital
Nantes, France
Saint-Louis Hospital, Paris
Paris, Île-de-France Region, France
Necker Hospital, Paris
Paris, Île-de-France Region, France
Charité-Universitätsmedizin, Berlin
Berlin, Germany
Charité-Universitätsmedizin,
Berlin, Germany
Vall d'Hebron Hospital
Barcelona, Spain
Bellvitge University Hospital
Barcelona, Spain
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland