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. Author manuscript; available in PMC: 2017 Jun 1.
Published in final edited form as: Kidney Int. 2016 Apr 23;89(6):1372–1379. doi: 10.1016/j.kint.2016.02.027

Figure 1. Opportunities to use biomarkers in late-phase acute kidney injury trials.

Figure 1

Diagnostic biomarkers can help enroll a subpopulation of patients with a given type of acute kidney injury (AKI), such as acute tubular necrosis (ATN). Prognostic biomarkers can be used to enroll a subpopulation who are at greater risk of poor clinical outcomes including AKI progression. Pharmacodynamic biomarkers can be used to assess AKI treatment effects that may be either beneficial or harmful (i.e., efficacy and safety outcomes). These biomarkers may also help define who is responding well to the intervention (to determine whether the dose or agent should be changed). Clinically Meaningful Outcomes: therapies showing promise with favorable pharmacodynamic biomarker response (possibly in the vanguard phase of trial rollout) can be tested in longer-duration trials, or trials with larger sample sizes, to assess therapy effects on clinically meaningful outcomes, such as receipt of acute dialysis, progression to chronic kidney disease or end-stage renal disease, mortality, length of hospital stay, hospital readmissions, patient symptoms, and quality of life.