Study Comparing Blood Tests and Molecular Analysis to Detect Kidney Transplant Rejection in Patients Undergoing Kidney Biopsy

What this Trial Is About

Researchers are investigating the connection between donor-derived cell-free DNA DD-cfDNA levels, HLA antibodies in blood, and the Molecular Microscope Diagnostic System MMDx results in kidney transplant patients. The study aims to improve the detection of kidney transplant rejection, as current tests like creatinine, urine protein, histology, and donor-specific antibody tests often miss rejection or produce false results. MMDx offers a molecular assessment of rejection and injury, and the new Prospera DD-cfDNA blood test is being evaluated against these methods to better identify different types of rejection and kidney injury. The study involves patients with functioning kidney transplants who are undergoing biopsies for clinical reasons. Blood samples will be taken to measure DD-cfDNA using the Prospera test and to assess HLA antibodies centrally. Kidney biopsy samples will also be analyzed using the MMDx system. Researchers will compare DD-cfDNA levels at the time of indication biopsies with MMDx results, histology, and HLA antibody status to calibrate and evaluate the accuracy of the Prospera test. Participants will contribute blood samples and kidney biopsy results that are collected as part of their standard care. The study will analyze about 600 blood samples and 300 biopsies, with data collected over several years. Researchers will measure outcomes related to the calibration of the Prospera test for detecting T cell-mediated rejection, antibody-mediated rejection, and kidney injury. The study also assesses whether the Prospera blood test can replace kidney biopsy as a less invasive method for monitoring transplant rejection and injury.

Trifecta-Kidney cfDNA-MMDx Study