Biomarkers—objective, measurable characteristics of biological processes—are critical to assess the effects of investigational drugs on people during clinical trials. Acute kidney injury (AKI) is particularly difficult to measure and detect early. To identify kidney conditions, clinicians often rely on measuring creatinine, but changes in creatinine levels are typically not noticeable until GFR has decreased by at least 50 percent, which is challenging for AKI diagnosis.

More informative AKI biomarkers could be used to assess drug efficacy and safety, diagnose AKI, monitor AKI progression, and apply interventions that can improve patient outcomes. The goal of this project was to stimulate the identification, advancement, and use of AKI biomarkers for use in drug development.