Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification

Clinical Pharmacology and Therapeutics
Ru ChenShashi Amur

Abstract

The Biomarker Qualification Program was established at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) to expedite the integration of promising biomarkers across multiple drug development programs. The first set of biomarkers qualified in 2008 consisted of seven nonclinical safety biomarkers for the detection of acute drug-induced nephrotoxicity in rats, and included urinary kidney injury molecule-1 (KIM-1). This article discusses the use of KIM-1 in drug development and research before and after CDER's qualification of KIM-1. Use was determined by analyzing relevant documents identified by keyword searches using three databases: 1) an FDA internal database, Document Archiving, Reporting, and Regulatory Tracking System (DARRTS); 2) ClinicalTrials.gov; and 3) PubMed. The results indicate increased use of KIM-1 as a biomarker for detection of kidney injury in drug development programs reviewed by CDER, as well as in research following qualification.

References

Nov 6, 2003·American Journal of Physiology. Renal Physiology·Takaharu IchimuraJoseph V Bonventre
Sep 22, 2005·American Journal of Physiology. Renal Physiology·Vishal S VaidyaJoseph V Bonventre
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Citations

May 12, 2020·Frontiers in Pharmacology·Nadeeka S UdawatteChaminda J Seneviratne
Sep 22, 2021·Journal of the American Society of Nephrology : JASN·Jason H GreenbergUNKNOWN CKD Biomarker consortium

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