blue U.S. Food & Drug Administration (FDA)
green European Medicines Agency (EMA)
orange Pharmaceutical & Medical Devices Agency Japan (PMDA)
Several putative drug-induced kidney biomarkers, including those currently under investigation in the rat model, are being evaluated for their utility in monitoring patient renal safety in a series of studies that will characterize inter- and intra-subject variability, as well as the impact of gender, age, and diurnal variation in healthy volunteers. In collaboration with the FNIH Biomarkers Consortium, PSTC will also determine thresholds for drug-induced renal tubular injury. Biomarkers to be evaluated include: urinary albumin, urinary creatinine, urinary alpha-1-microglobulin, urinary beta-2-microglobulin, urinary calbindinD28, urinary clusterin, urinary cystatin c, urinary kidney injury molecule-1 (KIM-1), urinary IL-18, urinary total protein, urinary trefoil factor 3 (TFF3), serum cystatin c, urinary NAG, urinary GST-alpha, urinary GST-pi, urinary RBP4, urinary NGAL, urinary osteopontin, urinary Tamm-Horsfall Protein (uromodulin), urinary VEGF, and urinary connective tissue growth factor (CTGF). Newly qualified biomarkers will enable safer drugs to be developed in order to reduce drug-induced injury in patients.