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COMPLETED
NCT04774575
NA

Non-Invasive Biomarker Strategy Integrating Dd-cfDNA Versus Biopsy-Based Monitoring in Kidney Transplant Recipients

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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