Endpoints for Clinical Trials of Acute Kidney Injury.

BACKGROUND: The selection of appropriate endpoints is critical to the success of any clinical trial. Endpoints need to be precisely defined and need to provide an appropriate balance between sensitivity for detection of the effects of the intervention of interest and specificity for the outcome of interest.

SUMMARY: In acute kidney injury (AKI), the 2 most common endpoints utilized either rely on small, short-term changes in serum creatinine or are a composite of longer term major adverse kidney events, including death, need for dialysis, and a persistent decline in kidney function. Key messages: Numerous issues affecting the potential utility of these endpoints are discussed that need to be carefully considered when selecting appropriate endpoints in the design of AKI trials.