Noninvasive monitoring of nephrotoxicity is challenging.
Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood
urea nitrogen, and serum creatinine, and urinary markers, such as urinary
volume, specific gravity, or osmolality, protein, fractional electrolyte
excretion, or sediment examination). Although many of these measurements are
valid indicators of renal function, there is a vast gap to overcome for early
detection of kidney damage to identify nephrotoxic biomarkers with high
sensitivity and specificity. There is promise in utilizing urinary biomarkers
as an indicator of nephron toxicity. This program has taken on work to help
qualify by FDA/EMA protein biomarkers like clusterin and Renal Papillary
Antigen (RPA-1) in rats, has published work to identify urinary biomarkers, and
defined technical best practices for protein biomarker evaluation and
interpretation. There have been efforts ongoing to characterize on a
multi-laboratory program to investigate kidney region-specificity of microRNA
(miRNA) candidates in rodents is in its final phase.
This webinar will also cover the quantification of laser capture microdissection (LCM) of nephron segments (glomerulus, proximal tubule, a loop of Henle, collecting duct). Urinary clusterin and RPA-1 are now qualified biomarkers by the Food and Drug Administration for some context of use. Urinary clusterin is approved for use in detecting acute drug-induced renal tubule alterations, and urinary RPA-1 is a qualified biomarker for voluntary use in detecting acute drug-induced renal tubule alterations. This webinar will cover the utility, promises, and challenges in using biomarkers of nephrotoxicity.
- Share the development of the nephrotoxicity biomarker and its utility and promises.
- Provide developers point of view for biomarker development point of view.
- Share the essential components required for the biomarker development process and will help attendees with an understanding of criteria they would need to go through the qualification process.