Bridging the Gap Between Preclinical and Clinical Evaluation of Therapeutic Candidates

Session 3

Biomarkers for Early Prediction of Acute Kidney Injury

Prasad Devarajan, M.D.
Cincinnati Children’s Hospital Medical Center

Acute kidney injury (AKI), previously referred to as acute renal failure (ARF), represents a common and devastating problem in clinical medicine. Despite significant improvements in therapeutics, the mortality and morbidity associated with AKI remain high. A major reason for is the lack of early markers for AKI, and hence an unacceptable delay in initiating therapy. Fortunately, the application of innovative technologies such as functional genomics and proteomics to human and animal models of AKI has uncovered several novel biomarkers. The most promising of these have recently been translated from the bench to the bedside. These include biomarker panels in plasma (NGAL and cystatin C) and urine (NGAL, KIM-1, IL-18). It is likely that the AKI panels will be useful for timing the initial insult, and assessing the duration and severity of AKI. It is also probable that the AKI panels will distinguish between the various etiologies of AKI, and predict clinical outcomes. Furthermore, AKI biomarkers may play a critical role in expediting the drug development process by providing early, non-invasive tools for the detection of nephrotoxicity. It will be important in future studies to validate the sensitivity and specificity of these biomarker panels in clinical samples from large cohorts and from multiple clinical situations. Such studies will be markedly facilitated by the development of commercial tools for the reproducible measurement of biomarkers across different laboratories.

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