EU-TRAIN IMPACT (EU-TRACER)

This randomized trial is based on the hypothesis that the combined use of (1) biomarkers including non‐invasive biomarkers in peripheral blood and urine predicting anti‐donor immunological activation or quiescence, and high/low risk clustering using the transcriptional changes in allograft tissue samples using gene expression assessment and (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow‐up of kidney transplant patients without the need for invasive surveillance allograft biopsies to assess allograft rejection in clinically stable kidney transplant patients. We therefore propose a with/without, European, multicenter, prospective randomized and biomarker‐guided trial.

Population: adult | Intervention type: therapeutic medicinal product