Transformation

Improve Diagnosis of Kidney Injury

“Kidney function is important for day-to-day living. You can afford to lose one kidney, as can be seen with live kidney donors, but once you lose 75 percent of function then you start to suffer from kidney failure. Complications can be quite serious and untreated kidney failure would lead to death. So, kidney safety is an important issue that comes up in drug development.”
— Stefan Sultana, M.D., Renal Safety Expert within the Patient Safety Group of AstraZeneca and Kidney Safety Project Team Member

In 2018, the FNIH Biomarkers Consortium achieved an unprecedented milestone by receiving the first ever qualification of a clinical safety biological marker (biomarker) awarded by the U.S. Food and Drug Administration (FDA). The qualification applies to a composite measure of six urine biomarkers that reliably change in response to drug-induced kidney injury prior to irreversible damage and earlier than traditional biomarkers. This set of biomarkers can now be used to aid in the detection of acute kidney injury in healthy volunteers during early phase clinical trials. It will help improve the development of safe and effective medicines for patients where concern has been raised that an investigational drug may cause kidney injury.

This major milestone was made possible by the relentless efforts of government, not-for-profit and industry partners sharing intellectual and financial resources to fast-track the development of these critical biomarkers. The pathway set forth by the team may help others submitting biomarkers for qualification by the FDA, explained Stefan Sultana, M.D.,: “The cutting-edge is a lonely place to be because no one has been down this path before, so we're developing new science and new ways of doing things with the regulatory agencies. Hopefully the lessons we learned make it a lot easier for other groups to pursue qualification of safety biomarkers.”