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464 Creating Pragmatic Tools for Reliable Kidney Function Measurement in Patients with Kidney Impairment

Published online by Cambridge University Press:  03 April 2024

Levi Hooper
Affiliation:
University of Michigan
Amit Pai
Affiliation:
University of Michigan
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Abstract

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OBJECTIVES/GOALS: Estimating kidney function for drug dosing poses safety and efficacy concerns with critical medications. This study aims to develop a pragmatic method for measuring kidney function, ensuring that critical clinical decision points based on kidney function are universally applicable to all patients, leading to improved health outcomes. METHODS/STUDY POPULATION: This is a single-dose pharmacokinetic (PK) study to evaluate the concordance between iopamidol- and iohexol-measured glomerular filtration rate (mGFR), as determined by their respective serum clearances, in a cohort of 24 adults with varying kidney function. Participants with estimated glomerular filtration rates (CKD-EPI eGFRcr) ranging from >30 to 120 mL/min will be recruited from the Michigan Medicine health system. Enrolled participants will be stratified into 3 kidney function groups based on conventual kidney dosing considerations. IV micro doses of iohexol and iopamidol will be administered, followed by blood sampling. PK analysis will be used to compare the clearance of these substances. The agreement between iohexol and iopamidol in measuring GFR will be assessed via bioequivalence analysis. RESULTS/ANTICIPATED RESULTS: We expect no statistically significant difference between iopamidol and iohexol CL due to the high similarity of iopamidol and iohexol molecular and PK properties. We also expect that the ordinary least square regression analysis of iopamidol mGFRand iohexol mGFR will show limited variability across GFR measurements. These expected results will support the use of iopamidol as a marker of mGFR and its interchangeability with the gold standard iohexol. DISCUSSION/SIGNIFICANCE: Addressing eGFR errors is crucial for accurately dosing critical medications. This study aims to develop a novel mGFR methodology that accommodates various kidney function levels. This will enable precision dosing and streamline clinical trials. It also eliminates biological variability, enhancing generalizability and health outcomes.

Type
Precision Medicine/Health
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2024. The Association for Clinical and Translational Science