PMID- 29761868
OWN - NLM
STAT- MEDLINE
DCOM- 20190916
LR  - 20191210
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 104
IP  - 6
DP  - 2018 Dec
TI  - Evaluating the Use of KIM-1 in Drug Development and Research Following FDA 
      Qualification.
PG  - 1175-1181
LID - 10.1002/cpt.1093 [doi]
AB  - 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.
CI  - (c) 2018 American Society for Clinical Pharmacology and Therapeutics.
FAU - Chen, Ru
AU  - Chen R
AD  - Immediate Office, Office of Translational Sciences, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Sanyal, Sarmistha
AU  - Sanyal S
AD  - Immediate Office, Office of Translational Sciences, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Thompson, Aliza
AU  - Thompson A
AD  - Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, 
      Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug 
      Administration, Silver Spring, Maryland, USA.
FAU - Ix, Joachim H
AU  - Ix JH
AD  - Division of Nephrology-Hypertension, School of Medicine, University of California 
      San Diego, La Jolla, California, USA.
FAU - Haskins, Kylie
AU  - Haskins K
AD  - Immediate Office, Office of Translational Sciences, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Muldowney, Laurie
AU  - Muldowney L
AD  - Immediate Office, Office of Translational Sciences, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Amur, Shashi
AU  - Amur S
AD  - Immediate Office, Office of Translational Sciences, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
LA  - eng
GR  - FD999999/Intramural FDA HHS/United States
GR  - K24 DK110427/DK/NIDDK NIH HHS/United States
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20180515
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Biomarkers, Pharmacological)
RN  - 0 (HAVCR1 protein, human)
RN  - 0 (Hepatitis A Virus Cellular Receptor 1)
SB  - IM
MH  - Acute Kidney Injury/chemically induced/diagnosis/*urine
MH  - Animals
MH  - Bibliometrics
MH  - Biomarkers, Pharmacological/*urine
MH  - Clinical Trials as Topic
MH  - Databases, Factual
MH  - Drug Approval/*methods
MH  - Drug Development/*methods
MH  - Hepatitis A Virus Cellular Receptor 1/*metabolism
MH  - Humans
MH  - Observational Studies as Topic
MH  - Prognosis
MH  - PubMed
MH  - Risk Assessment
MH  - Time Factors
MH  - United States
MH  - *United States Food and Drug Administration
MH  - Urinalysis
PMC - PMC6226328
MID - NIHMS961296
COIS- Conflict of Interest/Disclosure The authors declared no competing interests for 
      this work.
EDAT- 2018/05/16 06:00
MHDA- 2019/09/17 06:00
PMCR- 2019/12/01
CRDT- 2018/05/16 06:00
PHST- 2018/03/01 00:00 [received]
PHST- 2018/04/10 00:00 [revised]
PHST- 2018/04/13 00:00 [accepted]
PHST- 2018/05/16 06:00 [pubmed]
PHST- 2019/09/17 06:00 [medline]
PHST- 2018/05/16 06:00 [entrez]
PHST- 2019/12/01 00:00 [pmc-release]
AID - 10.1002/cpt.1093 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2018 Dec;104(6):1175-1181. doi: 10.1002/cpt.1093. Epub 2018 
      May 15.