Abstract: FR-PO750

Clinical Study Results of a Real-Time Point-of-Care Glomerular Filtration Rate Measurement

Session Information

Category: Glomerular

  • 1004 Clinical/Diagnostic Renal Pathology and Lab Medicine

Authors

  • Dorshow, Richard B., MediBeacon Inc., Saint Louis, Missouri, United States
  • Debreczeny, Martin, MediBeacon Inc., St Louis, Missouri, United States
  • Johnson, James R., MediBeacon Inc., St Louis, Missouri, United States
  • Shieh, jeng-jong, MediBeacon Inc., St Louis, Missouri, United States
  • Rogers, Thomas E, MediBeacon Inc, St Louis, Missouri, United States
  • Martin, Kevin J., Saint Louis University Med Ctr, St. Louis, Missouri, United States
  • Coyne, Daniel W., Washington University School of Medicine, St. Louis, Missouri, United States
Background

Real-time point-of-care measure of glomerular filtration rate (mGFR) would permit rapid diagnosis of acute kidney injury and precise determination of CKD. Clearance pharmacokinetics of the fluorescent agent MB-102 was measured in the plasma and correlated with noninvasively measured transdermal fluorescence for subjects with normal kidney function to Stage 4 CKD.

Methods

Blood samples were taken in 60 subjects with eGFR from normal to 19 mL/min/1.73m2 over a period of 12hr post simultaneous administration of MB-102 and iohexol, and urine collected to assess percent excretion. A noninvasive detection device simultaneously measured the transdermal fluorescence from MB-102.

Results

Plasma pharmacokinetics displayed the expected 2 compartment model of a vascular-tissue equilibrium phase followed by renal excretion only. The GFR measured from the MB-102 plasma pharmacokinetics was highly correlated with the GFR measured from iohexol over the entire measured range of GFR values (r2=0.98). The time-dependence of the transdermal fluorescence from MB-102 monitored by our fluorescence detection device was highly correlated with that of the plasma (see figure from subject with normal mGFR). MB-102 was completely cleared by 12hr when mGFR was >60 mL/min/1.73m2. No serious nor significant adverse events were reported.

Conclusion


Point-of-care clinically amenable measured GFR for a range of kidney function from normal to Stage 4 CKD is demonstrated using transdermal fluorescence detection of the novel fluorescence tracer agent MB-102.

Funding

  • Commercial Support