Technical optimisation and clinical validation of a novel urinary biomarker for antibody-mediated rejection after kidney transplantation

Donor-specific antibodies (HLA-DSA) can cause a severe form of transplant kidney rejection (antibody-mediated rejection; ABMR), which is currently difficult to treat with standard immunosuppressive therapy. Early stages of ABMR often occur subclinically but are detrimental to the functional survival of transplant kidneys. HLA-DSA testing is routinely performed, but this test is a risk factor for ABMR, not a diagnostic marker. Currently, no diagnostic biomarker for (subclinical) ABMR is available for clinical use, and current clinical decisions rely solely on non-specific functional tests (serum creatinine, glomerular filtration rate, and proteinuria), leading to late diagnosis of ABMR, often at an irreversible stage. This C3 project aims to technically optimize and further clinically validate our recently developed innovative urine-based assay for non-invasive diagnosis of early ABMR. This assay will be the first to combine high diagnostic accuracy with a low cost per test. This assay is expected to significantly improve the clinical management of kidney transplant recipients.

Keywords:Kidney transplantation, Urinary biomarker, Proteomics

Disciplines:Kidney transplantation, Biomarker evaluation