Kidney Health Initiative (KHI)

KHI Pilot Projects 2013

Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy

Patient Care Issue:

Patients in the intensive care unit often develop acute kidney injury (AKI) and require continuous renal replacement therapy (CRRT), a procedure that differs significantly from outpatient dialysis. While the rate of acute kidney injury in the United States has doubled during the last 10 years, less than 20% of the drugs used have been studied with regard to appropriate dosing for patients in intensive care units (ICUs) receiving CRRT. As a result, clinicians and pharmacists often end up making best guesses in terms of dosages of life saving drugs in critically ill patients.

Challenge:

The growing number of cases of AKI, increasing use of CRRT, and reliance on a large number of potentially life-saving medications in these critically ill patients necessitate a better understanding of basic pharmacokinetics in this setting. Standardized pharmacokinetics guided drug dosing studies during the pre-approval development process are urgently needed for drugs likely to be used in critically ill patients, and similar studies should be conducted on currently approved drugs commonly used in these patients.

KHI Solution:

A KHI workgroup, including FDA staff, evaluated medication dosing during CRRT and prioritized drugs or classes of drugs to help generate key data to improve treatment for these critically ill patients.

Status:

The workgroup successfully evaluated and proposed key considerations in the assessment of PK/drug dosing during CRRT as charged. The workgroup's recommendations were published in the January 2015 issue of the Clinical Journal of the American Society of Nephrology which can be viewed here.

The workgroup presented its recommendations at an open workshop titled "Standardized Pharmacokinetics Assessment in Patients Receiving Continuous Renal Replacement Therapy (CRRT)" on November 11, 2014, at the Pennsylvania Convention Center.

To view the workshop's agenda and the captured content for each session, please click here.

Deliverable:

White paper and workshop.

Timeframe for completion:

Project Completed.

KHI Workgroup:
Co-Chairs:
  • George R. Aronoff, MD
    University of Louisville
  • Stuart Goldstein, MD
    Cincinnati Children’s Hospital (KHI Board of Directors)
  • Thomas D. Nolin, PharmD, PhD, FASN
    University of Pittsburgh
Members:
  • Patrick Archdeacon, MD
    Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA (KHI Co-Chair)
  • William Fissell, MD
    Vanderbilt University
  • Michael Flessner, MD, PhD
    National Institute of Diabetes and Digestive and Kidney Diseases (KHI Board of Directors Member)
  • Lokesh Jain, PhD
    Office of Clinical Pharmacology (OCP), FDA
  • Rajnikanth Madabushi, PhD
    Office of Clinical Pharmacology (OCP), FDA
  • Rajnish Mehrotra, MD, FASN
    Harborview Medical Center
  • Shiew Mei Huang, PhD, FCP
    Office of Clinical Pharmacology (OCP), FDA
  • John K. Leypoldt, MD
    Baxter International Inc.
  • Kellie Reynolds, PharmD
    Office of Clinical Pharmacology (OCP), FDA
  • Prabir Roy-Chaudhury, MD, PhD, FASN
    University of Cincinnati, (KHI Co-Chair)
  • Jennifer Witcher, PhD
    Eli Lilly and Company
  • Lei Zhang, PhD
    Office of Clinical Pharmacology (OCP), FDA
  • Issam Zineh, PharmD, MPH
    Office of Clinical Pharmacology (OCP), FDA