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Current Approaches for Sensitive Detection of Drug-Induced Acute Kidney Injury pp. 143-164 $100.00
Authors:  (Yutaka Tonomura, Mitsunobu Matsubara, Takeki Uehara, Drug Safety Evaluation, Drug Developmental Research Laboratories, Shionogi & Co., Ltd., Toyonaka, Osaka, Japan, and others)
Abstract:
The kidney is particularly vulnerable to various drugs. Early screening of drug induced acute kidney injury (AKI) is therefore critical for its clinical management, leading to a better outcome of clinical treatment. For the pharmaceutical industry, drug induced
AKI is a major concern in the early stage of preclinical safety evaluations. One major limitation in early detection of AKI has been the low detection power of traditional biomarkers, such as creatinine and blood urea nitrogen. Recent advances in basic and clinical research have provided several valuable biomarkers for early detection of AKI for the preclinical safety evaluation of drugs, clinical trials, and early therapeutic intervention. Serum cystatin c (CysC) has been identified as an attractive alternative biomarker for estimation of the glomerular filtration rate. Additionally, several
biomarkers, such as kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin, interleukin-18 and liver type fatty acid binding protein, have been discovered and their usefulness has been evaluated in cross-sectional studies. Recently, the Predictive Safety Testing Consortiumís Nephrotoxicity Working Group, a collaboration between biotech and pharmaceutical industries, the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and academia, published a report concerning the qualification of seven urinary nephrotoxic biomarkers, including total protein, albumin, KIM-1, clusterin (CLU), β2-microglobulin, CysC, and trefoil factor 3, for particular uses in regulatory decision-making. Furthermore, the International Life Sciences Institute Health and Environmental Sciences Institute reported an extensive data package on the four urinary nephrotoxic biomarkers glutathione S-transferase α (GSTα), GSTμ, renal papillary antigen-1 and CLU to the FDA and the EMEA. This chapter describes the usefulness of these biomarkers with respect to clinical and preclinical usage and the possible mechanisms that underlie their alterations in serum and/or urine. Finally,
we discuss the future view of AKI biomarkers. 


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Current Approaches for Sensitive Detection of Drug-Induced Acute Kidney Injury pp. 143-164