Abstract: TH-OR38
Transdermal Glomerular Filtration Rate Measurement: Clinical Results From a Pilot Multicenter Study Establishing Feasibility and Efficacy
Session Information
- Technology-Based Approaches in Nephrology
November 03, 2022 | Location: W308, Orange County Convention Center‚ West Building
Abstract Time: 04:30 PM - 04:39 PM
Category: Bioengineering
- 300 Bioengineering
Authors
- Dorshow, Richard B., MediBeacon Inc., Saint Louis, Missouri, United States
- Debreczeny, Martin, MediBeacon Inc., Saint Louis, Missouri, United States
- Shieh, Jeng-Jong, MediBeacon Inc., Saint Louis, Missouri, United States
Background
Point-of-care measured (not estimated) glomerular filtration rate has been a goal of nephrologists for the last 30 years. To this end, a fluorescent GFR tracer agent, relmapirizin, has been rationally designed and 24 standard nonclinical assays 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 relmapirizin is a GFR agent in humans by comparison to iohexol,
Establish that the GFR as measured by the transdermal fluorescence excretion rate matches the plasma GFR.
This combination product was evaluated on 120 subjects covering three clinical sites.
Methods
Subjects were enrolled with GFR values from normal to Stage 4 CKD values, and for all six skin colors on the Fitzpatrick Skin Scale (FSS). Relmapirizin and iohexol were administered IV in consecutive boluses, and blood samples were taken periodically over the subsequent 12 hours. Prior to agent dosing, the transdermal sensor was placed on the chest of each subject and fluorescent readings were initiated. Urine was collected post-dosing.
Results
The plasma-derived GFR measured from relmapirizin matched the plasma-derived GFR measured from iohexol. An algorithm was developed to convert the transdermal fluorescence measurement directly into an indexed GFR, applicable to the entire GFR range and for all skin colors (Figure 1). The % administered relmapirizin dose recovered in the urine matched that of iohexol. No serious nor significant adverse events were reported.
Conclusion
Clinically amenable point-of-care measured GFR has been demonstrated for subjects with a range of GFR values and for all skin colors, thus validating this methodology. Data and fits will be shown in this oral presentation.
The transdermal GFR (tGFR) correlates to the indexed plasma GFR (nGFR).
Funding
- Commercial Support –