On Oct. 25, 2018, The Foundation for the National Institutes of Health, Biomarkers Consortium and the Critical Path Institute Predictive Safety Testing Consortium (PSTC) announced they had received the first ever qualification of a clinical safety biomarker awarded by the U.S. Food and Drug Administration (FDA) – a major milestone that will improve the detection of drug-induced kidney injury in early phase drug development. The newly qualified biomarker can now be used in Phase I clinical trials to aid in the detection of acute kidney tubular injury in healthy volunteers. This will help improve the development of safe and effective medicines where concern has been raised that an investigational drug may cause kidney injury.

This significant achievement was made possible by the efforts of the Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers Project (Kidney Safety Project) team. Its members include the FNIH, C-Path’s PSTC Nephrotoxicity Working Group, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), academia and industry, with advice from the FDA.

This qualification applies to a single composite measure of six urine biomarkers, to be used in conjunction with traditional measures of kidney function. It measures the change over time of the urine biomarkers that the team selected for tracking acute damage to the kidney tubules. The qualification submission to the FDA included analyses of data collected from a Normal Healthy Volunteer Study funded by the PSTC and a collaborative Harvard-Merck Study of cancer patients with mesothelioma treated with cisplatin, a common chemotherapy drug known to cause kidney injury.