The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™

CompletedOBSERVATIONAL
Enrollment

32

Participants

Timeline

Start Date

June 13, 2017

Primary Completion Date

September 20, 2017

Study Completion Date

September 20, 2017

Conditions
Kidney DiseasesRenal Insufficiency, ChronicAcute Kidney InjuryUrologic DiseasesRenal Insufficiency
Interventions
DEVICE

VFI

The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

DEVICE

Iohexol

Iohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.

Trial Locations (2)

35294

University of Alabama Birmingham, Division of Nephrology, Birmingham

78209

ICON Early Phase Services, LLC, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

FAST BioMedical

INDUSTRY