KHI Current Project

Developing a Roadmap to Accelerate the Expansion of AKI Biomarkers for Drug Development


Biomarkers—objective, measurable characteristics of biological processes—are critical to assess the effects of investigational drugs on people during clinical trials. Acute kidney injury (AKI) is particularly difficult to measure and detect early. To identify kidney conditions, clinicians often rely on measuring creatinine, but changes in creatinine levels are typically not noticeable until GFR has decreased by at least 50 percent, which is challenging for AKI diagnosis. More informative AKI biomarkers could be used to assess drug efficacy and safety, diagnose AKI, monitor AKI progression, and apply interventions that can improve patient outcomes.


The overall goal of this project was to stimulate the identification, advancement, and use of AKI biomarkers for use in drug development.
Roadmap for Accelerating the Development of Biomarkers for Acute Kidney Injury

KHI acknowledges and thanks the diverse stakeholders, including but not limited to FDA, industry, researchers, and clinicians who contributed to this roadmap. A special thanks to the workgroup that led this effort as well as Jacqueline Brown and Sarah Lichtner at Nexight Group for their assistance.

Workgroup Members

Role Name Organization
ChairRaymond C. Harris, MD, FASNVanderbilt University
MemberJoseph V. Bonventre, MD, PhD, FASNBrigham and Women's Hospital
MemberJohn-Michael Sauer, PhDCritical Path Institute
MemberAliza Thompson, MD, MSU.S. Food and Drug Administration
MemberVishal S. Vaidya, PhDPfizer / Brigham & Women's Hospital
MemberMelissa WestASN Alliance for Kidney Health
KHI Board of Directors Liaison Amit Sharma, MD, FASNBayer Pharmaceuticals

In addition to the roadmap, Nexight Group and KHI staff compiled a list of Biomarkers Reported to be Useful in AKI as a reference here.