HistoMap AlloSure Renal Biopsies Observational Research Study

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.

Inclusion Criteria: * Adult age 18 or older at time of informed consent * Kidney transplant recipient with a functioning allograft * Undergoing an indicated biopsy per transplant center's SOC, based on any traditional metrics of function (eGFR, Serum Creatinine, proteinuria) or donor-specific antibodies (DSA) or dd-cfDNA * Enrolled within 14 days prior to biopsy. * Willing and able to provide informed consent to participate in the study. * Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments. Exclusion Criteria: * Has received a multi-organ transplant (e.g., liver-kidney, heart-kidney) * Pregnant at the time of enrollment. * Receiving kidney from patient's homozygous twin * Deemed by researchers to be unsuitable for clinical study, due to known medical or psychological condition(s) that might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of study outcomes. * Active systemic bacterial or fungal infection within 14 days prior to biopsy. * Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer.