Novel Urinary Kidney Safety Biomarkers

This study determing the critical path institute (C-Path) a formal consultation between its predictive safety testing Consortium (PSTC); and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) was resulting in an agreement on a first of its kind approach; to compare the levels of 8 novel urinary kidney safety biomarkers in healthy Japanese volunteers; to data collecting on these same biomarkers in healthy Western volunteers.

But this the study results are expecting to provide clinical evidence for PMDA evaluation; to support utilization of these biomarkers to help guide decisions in early stage clinical trials to ensure the safety of trial participants; study, to be conducted in Japan by PSTC member companies;by comparing healthy Japanese volunteers with subjects;Food and Drug Administration (FDA) and European Medicines Agency (EMA) submissions on these novel kidney safety biomarkers.


But the results from the study informing subsequent work in Japan to be defined during future consultations between PSTC and PMDA;By measuring the biomarkers in Japanese subjects in this study include clusterin (CLU), cystatin C (CysC);kidney injury molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), neutrophil gelatinase associating lipocalin (NGAL), osteopontin (OPN), albumin (ALB) and total protein.

Drug inducing kidney injury is a serious issue that can occur during drug development; but C-Path Biomarkers Program Officer and Executive Director of PSTC; Results from this and other PSTC clinical safety biomarker projects are designing to generate critical data to support safety decisions about whether to pause or discontinue early phase clinical trials at the testing dose and duration.

Measures of kidney function

But FDA issued its first ever qualification of a clinical safety biomarker;but a single composite measure of 6 urine biomarkers using in conjunction with traditional measures of kidney function;to PSTC and the Foundation for the National Institutes of Health Biomarkers Consortium; but FDA qualification of a clinical kidney safety biomarker and our latest interactions with PMDA exemplify C-Path’s expanding global reach and our role as a catalyst in the development of new approaches to advance medical innovation and regulatory science.

Presentations, panel discussions and a poster session will address emerging and important topics in this rapidly evolving field, including the role of miRNA;and small circulating RNA as safety biomarkers; safety testing, drug efficacy and disease diagnosis; genomics and epigenetics; and evidentiary considerations across regulatory agencies in Japan.