Biomarkers Consortium - Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers

The Biomarkers Consortium’s Kidney Safety Project aims to qualify novel biomarkers of drug-induced acute kidney injury. The project is designed to include a learn-and-confirm phase. The learn phase consists of retrospective analyses of mesothelioma patients and healthy volunteer data to establish a prioritization for the novel biomarkers that seem most promising for the prospective analyses. Biomarkers being evaluated include: urinary albumin, urinary creatinine, urinary alpha-1-microglobulin, urinary beta-2-microglobulin, urinary calbindinD28, urinary clusterin, urinary cystatin c, urinary kidney injury molecule-1 (KIM-1), urinary IL-18, urinary total protein, urinary trefoil factor3 (TFF3) serum cystatin c, urinary NAG, urinary GST-alpha, urinary GST-pi, urinary RBP4, urinary NGAL, urinary osteopontin, urinary Tamm-Horsfall Protein (uromodulin), urinary VEGF, and urinary connective tissue growth factor (CTGF). The predictive validity of these promising biomarkers will be confirmed through the prospective analyses of data collected from two observational clinical trials that treat patients with either aminoglycosides or cisplatin treatment—aiming to validate important biomarkers of acute kidney injury (AKI) that perform better than serum creatinine and BUN (the currently used biomarkers of AKI).


  • To provide the data needed to advance the clinical qualification and broader acceptance of new translational biomarkers for monitoring kidney safety to support early clinical drug development.
  • To improve the clinical diagnosis of acute drug-induced kidney injury during drug development.


FNIH Press Release (October 25, 2018): FNIH Biomarkers Consortium and Critical Path Institute Achieve the First Ever Qualification of a Clinical Safety Biomarker by the U.S. Food and Drug Administration

FDA Letter of Support – Submitted by Critical Path Institute's (C-Path) Predictive Safety Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG) in support of further use of urinary biomarkers Osteopontin and Neutrophil Gelatinase-associated Lipocalin (NGAL) for kidney safety monitoring in early clinical drug development


Public-Sector Partners:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U.S. Food and Drug Administration (FDA)

Private-Sector Partners:
Amgen, Inc.*
AstraZeneca Pharmaceuticals LP*
Critical Path Institute – Predictive Safety Testing Consortium*
Eli Lilly and Company
Johnson & Johnson*
Eli Lilly and Company*
Merck Sharp & Dohme Corp.*
Pfizer Inc.*

Academic Partners:
Brigham and Woman's Hospital
Dana Farber Cancer Institute
MD Anderson Cancer Center
University of Minnesota
University of Southern California
University of Utah

*Provided financial or in-kind support for this program.

FNIH Contact

Steve Hoffmann, Director, Inflammation and Immunity,