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Semin Nephrol. 2019 Mar;39(2):202-214. doi: 10.1016/j.semnephrol.2018.12.008.

Translational Safety Biomarkers of Kidney Injury.

Author information

1
Merck Research Laboratories, Department of Safety Assessment and Laboratory Animal Resources, Merck & Co, Inc, West Point, PA. Electronic address: sean_troth@merck.com.
2
Merck Research Laboratories, Department of Safety Assessment and Laboratory Animal Resources, Merck & Co, Inc, West Point, PA.
3
Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

Abstract

Acute kidney injury continues to be a common problem and there continues to be a medical need for sensitive translational biomarkers for clinical monitoring. The past decade has yielded unprecedented progress in fundamental research into novel kidney biomarker evaluation and the mechanistic understanding of kidney injury; as such, these novel biomarkers increasingly are being used in preclinical drug development and in early clinical trials of drug candidates on a case-by-case basis, as well as in medical and veterinary practice. With the recent successful clinical qualification of a subset of novel accessible biomarker candidates for use in early phase clinical trials, continued clinical evaluation may enable expanded regulatory qualification for more generalized clinical use. This review provides a comprehensive overview about the discovery and development of kidney safety biomarkers with a focus on current progress in nonclinical research, progress toward translation to the clinic, and perspectives on future opportunities.

KEYWORDS:

Nephrotoxicity; prediction; translational biomarkers

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