Early Detection of Kidney Transplant Rejection Using Blood and Urine Tests to Measure Circulating Kidney DNA in Adults with Functioning Kidney Grafts

What this Trial Is About

Kidney transplantation is a key treatment for patients with end-stage renal disease, improving quality of life and survival compared to dialysis. Despite over 3,000 kidney transplants annually in France, many patients face graft rejection, diagnosed currently by invasive kidney biopsies using the Banff classification. Researchers are investigating non-invasive methods to detect and characterize kidney transplant rejection early by analyzing circulating kidney DNA and urinary chemokines in blood and urine samples. This observational study involves recruiting 319 kidney transplant patients undergoing kidney biopsy due to suspected graft rejection. Blood and urine samples will be collected within 24 hours before biopsy to measure circulating DNA from various kidney tissue types using digital PCR. The study aims to assess the diagnostic accuracy of these DNA markers and urinary chemokines to predict types of rejection, comparing results to the biopsy gold standard. Participants will be involved at the time of their biopsy hospitalization, with sample collection and monitoring of circulating DNA and chemokine levels. Researchers will evaluate the predictive performance of these biomarkers using statistical models and ROC curve analyses. The study will provide insight into non-invasive diagnostic tools for kidney transplant rejection, with data collection continuing until 2027.

Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection