A Device for Detection of Acute Kidney Injury

Summary This is a revised Phase I STTR application to develop and test a device to predict severe acute kidney injury (AKI). Prediction of future risk of developing Acute Kidney Injury (AKI) has been a goal for decades. The treatment of patients with severe AKI and severe AKI that requires dialysis (AKI-3 and AKI-D) is significantly different than for patients with mild-to-moderate AKI (AKI-1 to AKI-2). No currently available biomarkers are strong predictors of the development of severe AKI, nor can they differentiate AKI-1 and -2 from AKI-3 and -D. We have discovered that extensive cleavage of a protein occurs in the urine of patients with mild AKI that will progress to severe AKI. This cleavage does not occur in healthy controls or patients with mild AKI that will not progress to severe AKI. Preliminary data suggest that an assay that uses this cleavage to predict severe AKI will be both highly sensitive and highly specific. In this application, we propose to develop a point of care test that can detect the amount of cleavage of this protein. We will use this test to predict the future development of severe AKI.