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Proceedings Paper

Results of the first-in-human clinical trial for MB-102, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate
Author(s): Richard B. Dorshow; Martin P Debreczeny; Thomas C. Dowling
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Paper Abstract

The fluorescent tracer agent 2,5-bis[N-(1-carboxy-2-hydroxy)]carbamoyl-3,6-diaminopyrazine, designated MB-102, has been developed with properties and attributes necessary for use as a direct measure of glomerular filtration rate (GFR). Comparison to known standard exogenous GFR agents in animal models has demonstrated an excellent correlation. A clinical trial to demonstrate this same correlation in humans is in progress. This clinical trial is the first in a series of trials necessary to obtain regulatory clearance from the FDA. We report herein the comparison of plasma pharmacokinetics between MB-102 and the known standard exogenous GFR agent Iohexol in healthy subjects with normal renal function. Post simultaneous administration of both agents, blood samples over a period of 12 hours were collected from each subject to assess pharmacokinetic parameters including GFR. Urine samples were collected over this same period to assess percent injected dose recovered in the urine. Results indicate MB-102 is a GFR agent in humans from the comparison to the standard agent.

Paper Details

Date Published: 12 March 2015
PDF: 4 pages
Proc. SPIE 9339, Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications VII, 933906 (12 March 2015); doi: 10.1117/12.2078346
Show Author Affiliations
Richard B. Dorshow, MediBeacon, LLC (United States)
Martin P Debreczeny, MediBeacon, LLC (United States)
Thomas C. Dowling, Ferris State Univ. (United States)


Published in SPIE Proceedings Vol. 9339:
Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications VII
Samuel Achilefu; Ramesh Raghavachari, Editor(s)

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