Nonclinical Kidney: Phase II

FEASIBILITY1 SCOPING2 RESEARCH3 SUBMITTED4 QUALIFIED5

blue U.S. Food & Drug Administration (FDA)

green European Medicines Agency (EMA)

orange Pharmaceutical & Medical Devices Agency Japan (PMDA)

Overview

In Phase II of PSTC’s nonclinical qualification, the seven previously qualified biomarkers, plus serum cystatin c, urinary retinol-binding protein 4 (RBP-4), GST-alpha, GST-pi/mu, NAG, NGAL, osteoactivin, and osteopontin, are being further investigated for their mechanistic specificity, their potential to detect very early kidney injury (i.e. before microscopic evidence of injury to the tissue), their utility in monitoring injury reversibility, and their specificity to drug-induced renal injury.