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 is to stimulate the identification, advancement, and use of AKI biomarkers for use in drug development. The roadmap is anticipated to include:

  • The Unmet Need for AKI Biomarkers:
    1. Overview of challenge
    2. Trends, drivers, and opportunities for AKI biomarker use
    3. AKI Biomarker Contexts of Use
  • Gaps / Challenges to Advancing AKI Biomarkers
  • Activity Timelines to Accelerate Development


December 2021

Patient Care Issue

Since AKI is often preceded by or associated with prerenal or nephrotoxic influences (eg. drugs, cardiovascular conditions, blood loss, dehydration), the speed of diagnosing the underlying cause is key to the reversibility of AKI and patient recovery. If not caught quickly, AKI can lead to progressive kidney dysfunction and permanent kidney damage. In addition to supporting early diagnosis of AKI, improved tools are needed to:

  • Assess the susceptibility/risk of AKI in patients undergoing a procedure or developing sepsis;
  • Predict which patients are more likely to develop AKI as a response to a drug;
  • Predict which patients will respond to a drug to treat AKI;
  • Measure recovery/response to an intervention; and
  • Monitor AKI progression to CKD and/or end stage kidney disease (ESKD).


While many stakeholders—including nephrologists, clinicians, regulators, drug developers, biomedical researchers, and patients—could benefit from more informative biomarkers, a concerted effort is required to make them more available for widespread use in important contexts/scenarios. Stakeholders must come together to assess needs for and opportunities for AKI biomarkers, identify known AKI biomarkers and existing data to support their use, define current gaps and challenges, and outline next steps to support the advancement and use of AKI biomarkers.


Developing an AKI biomarker roadmap is the first step to encourage sharing of clinical data (e.g., through a consortia model), support biomarker adoption in the scientific community, increase AKI clinical studies and participation, and inform regulatory decisions. Ultimately, such an effort could help to accelerate treatment availability, reduce the cost of drug development, improve patient outcomes, and encourage development of innovative medical treatments.

Workgroup Members

Role Name Organization
ChairRaymond C. Harris, MD, FASNVanderbilt University
MemberJoseph V. Bonventre, MD, PhD, FASNBrigham and Women's Hospital
MemberJacqueline BowenNexight Group
MemberSarah LichtnerNexight Group
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