Six Novel Biomarkers May Improve Early Detection of Kidney Injury and Support Safer Drug Development

Researchers from the Critical Path Institute (C-Path) and Boston Medical Center (BMC) have identified six promising biomarkers that may offer earlier and more precise detection of drug-induced kidney damage. They also hold promise for enhancing drug safety monitoring during early-phase clinical trials.

Serum creatinine has long served as the standard biomarker for assessing kidney function, but its delayed response often limits its utility in early detection. Out of the eight biomarkers studied, six were found to be more responsive to kidney injury: clusterin, osteopontin, N-acetyl-β-d-glucosaminidase, kidney injury molecule-1, cystatin, and neutrophil gelatinase-associated lipocalin. According to researchers, most of these biomarkers originate in the kidney itself in response to injury or inflammation, offering a more direct and timely measure of renal stress.

Study findings suggest these markers could help detect injury in both healthy volunteers and patients undergoing treatment with nephrotoxic medications, such as certain chemotherapy agents. Their rapid detection capability supports more timely clinical decision-making, which could enhance patient safety and treatment outcomes.

Earlier detection of kidney damage can enable clinicians to adjust therapies before permanent injury occurs. While further validation is needed, integrating these biomarkers into routine monitoring protocols could reduce the incidence of drug-induced kidney injury and associated complications. This would not only benefit patients but also support the development of more tolerable treatment options by pharmaceutical developers.

“These biomarkers have the potential to make a real difference in how we monitor kidney health and manage patients at risk for kidney damage,” said Dr. Sushrut Waikar, Chief of Nephrology at BMC and the lead author of the study.

As part of a broader public-private collaboration—including C-Path’s Predictive Safety Testing Consortium and the Foundation for the NIH’s Biomarkers Consortium—this research exemplifies how cross-sector partnerships can accelerate the development of new clinical tools. These efforts represent a meaningful step toward advancing renal care and promoting safer medication practices.

Source

Waikar, Sushrut S, Robin Mogg, Amanda F Baker, Gyorgy Frendl, Michael Topper, Scott Adler, Stefan Sultana, et al. 2025. “Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and after Nephrotoxic and Ischemic Injury.” Clinical Pharmacology & Therapeutics, January. https://doi.org/10.1002/cpt.3531.