Clinical results from a pilot multi-center study using a novel fluorescent tracer agent for renal function measurement

Richard B. Dorshow; Jeng-Jong Shieh; Martin P. Debreczeny

doi:10.1117/12.2648541

17 March 2023 Clinical results from a pilot multi-center study using a novel fluorescent tracer agent for renal function measurement

Richard B. Dorshow, Jeng-Jong Shieh, Martin P. Debreczeny

Author Affiliations +

Proceedings Volume 12398, Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications XIV; 1239803 (2023) https://doi.org/10.1117/12.2648541
Event: SPIE BiOS, 2023, San Francisco, California, United States

Abstract

Point-of-care (POC) measured glomerular filtration rate (GFR) has been a goal of nephrologists for the last 30 years. To this end, a fluorescent GFR tracer agent, relmapirazin, with appropriate photophysical properties for transdermal detection has been rationally designed. Twenty-four standard nonclinical assays to evaluate toxicity as required by the FDA have been performed. Fluorescent detection instrumentation to acquire and process the emission signal from the agent through the skin has been developed. The pilot clinical study objectives were to: • Demonstrate relmapirazin is a GFR agent in humans by comparison to a known non-fluorescent standard agent, • Establish that the GFR as measured by the transdermal fluorescence excretion rate matches the standard labor-intensive non-POC plasma GFR. This combination product was evaluated on 120 subjects covering three clinical sites. Subjects were enrolled spanning normal to very impaired renal function, and for all six skin colors on the Fitzpatrick Skin Scale. Relmapirazin and the standard agent were intravenously administered in consecutive boluses. Prior to dosing, the transdermal sensor was placed on the chest of each subject and fluorescent readings were initiated. The plasma-derived GFR measured from relmapirazin matched the plasma-derived GFR measured from the standard agent. An algorithm was developed to convert the transdermal fluorescence measurement directly into a GFR, applicable to the entire GFR range and for all skin colors. No serious nor significant adverse events were reported. Clinically amenable point-of-care measured GFR has been demonstrated for subjects with a range of GFR values and for all skin colors.

Conference Presentation

Citation Download Citation

Richard B. Dorshow, Jeng-Jong Shieh, and Martin P. Debreczeny "Clinical results from a pilot multi-center study using a novel fluorescent tracer agent for renal function measurement", Proc. SPIE 12398, Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications XIV, 1239803 (17 March 2023); https://doi.org/10.1117/12.2648541

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