HistoMap AlloSure Renal Biopsies Observational Research Study - NCT07927374

Sponsor: CareDx Conditions: Kidney Transplant Rejection, T-Cell Mediated Rejection, Kidney Transplantation, Antibody Mediated Rejection The HistoMap AlloSure Renal Biopsies Observational Research Study (HARBOR) is a prospective, multicenter, observational cohort study of adult kidney transplant recipients undergoing a clinically indicated kidney allograft biopsy. The study will collect biospecimens and associated clinical data to support the development and evaluation of molecular approaches for assessing kidney allograft rejection. It will also examine relationships among histopathology, tissue-based gene expression profiling using HistoMap, donor-derived cell-free DNA (dd-cfDNA) measured using AlloSure, and clinical outcomes. As an observational study, HARBOR will not direct clinical care, and all diagnostic and treatment decisions will remain at the discretion of the treating clinicians in accordance with standard clinical practice. HARBOR will include enrollment of approximately 1,250 adult kidney transplant recipients undergoing clinically indicated kidney allograft biopsies at U.S. transplant centers. The study will prospectively collect blood and tissue specimens, biopsy findings, molecular test results, and associated clinical data to support research on kidney allograft rejection. Histopathologic findings will be assessed in relation to results from HistoMap, a tissue-based gene expression profiling assay, and AlloSure, a donor-derived cell-free DNA assay. Secondary analyses will evaluate agreement among diagnostic assessments and associations with kidney allograft function and outcomes. Participants will be classified into two observational cohorts using index-biopsy findings and AlloSure results. All participants will undergo an assessment at Month 1. Participants meeting criteria for Cohort 1 will have additional assessments at Months 3 and 6, with a final assessment at Month 12; participants in Cohort 2 will complete study follow-up at Month 1. The study will not assign or direct treatment, and all clinical management decisions will remain at the discretion of the treating clinicians according to standard of care.