Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury

  • Published on 01/08/2025
  •  Reading time: 7 min.

Sushrut S. Waikar 1, Robin Mogg 2, Amanda F. Baker 3, Gyorgy Frendl 4, Michael Topper 2, Scott Adler 5, Stefan Sultana 5, Runqi Zhao 1, Nicholas M. P. King 3, Steven P. Piccoli 6, John‐Michael Sauer 3, Steve Hoffmann 7, Irene Nunes 2, Frank D. Sistare 2

1 Department of Medicine and Section of Nephrology Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center Boston Massachusetts USA
2 Merck & Co., Inc. Rahway New Jersey USA
3 Critical Path Institute Tucson Arizona USA
4 Brigham and Women's Hospital Boston Massachusetts USA
5 AstraZeneca Cambridge UK
6 Neoteric Consulting Princeton New Jersey USA
7 Foundation for the National Institutes of Health North Bethesda Maryland USA
Takeda Pharmaceuticals Cambridge Massachusetts USA
Roche Diagnostic Solutions Tucson Arizona USA
Greensboro Georgia USA
BridgeBio, Inc. San Francisco California USA
Genmab, Inc. Westfield New Jersey USA
Chapel Hill North Carolina USA

Abstract

Two observational studies were conducted to support an initiative to qualify translational kidney safety biomarkers as clinical drug development tools that identify tubular injury prior to changes in estimated glomerular filtration rate (eGFR). Normal healthy volunteers provided three morning spot urine collections over 4 weeks. Patients undergoing surgical resection and intrathoracic cisplatin for malignant pleural mesothelioma provided urine samples pre‐ and postoperatively...

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