The FAST Plasma Volume (PV) Technology will aid in determining the plasma and interstitial volumes of end stage renal disease patients before and after dialysis therapy, providing a more precise understanding of pre and post dialysis volumes and extent of volume removal during the course of treatment.
This is a pilot, single site, open-label study designed to evaluate the safety, tolerability, and performance of the FAST plasma volume (PV) Technology in dialysis patients. Administration of VFI will occur within 28 days of screening. Patients will receive 1 dose of VFI and 1 dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of visible fluorescent injectate (VFI) and iohexol approximately 1 hour after completing dialysis. Patients will be discharged following completion of Day 1 activities. Patients will be seen and evaluated on their next 2 dialysis sessions for any adverse reaction by answering questions about their health, approximately on Day 3 and Day 8. A follow-up phone call will be performed on Day 31 (± 1 day).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
The bolus 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.
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
To measure quantitatively the ISV and PV of patients pre dialysis using the FAST PV Technology and iohexol measurement
Time frame: 1 day
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
To measure quantitatively the ISV and PV of patients post dialysis using FAST PV Technology and the iohexol measurement
Time frame: 1 day
Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
Directly compare quantitative difference of ISV and PV measured by the FAST PV Technology to the volume removed during dialysis
Time frame: 1 day
Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Directly compare quantitative difference of ISV and PV measured by the Iohexol measurement to the volume removed during dialysis
Time frame: 1 day
The Number of Patients Reporting Any Treatment-emergent Adverse Event.
To assess the safety and tolerability of visible fluorescent injectate (VFI)™ (employing the FAST PV Technology™) in chronic dialysis patients with extremely reduced or no renal function subjects will be monitored for adverse events and serious adverse events following administration of the first dose of the study drug through the end of the study. Treatment-emergent adverse events will be tabulated by system organ class, preferred term, and cohort. Treatment-emergent AEs will be further classified by severity and relationship to study product.
Time frame: 59 days
The Number of Patients Reporting Any Treatment-emergent Serious Adverse Event.
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To assess the safety and tolerability of visible fluorescent injectate (VFI)™ (employing the FAST PV Technology™) in chronic dialysis patients with extremely reduced or no renal function subjects will be monitored for adverse events and serious adverse events following administration of the first dose of the study drug through the end of the study. Treatment-emergent adverse events will be tabulated by system organ class, preferred term, and cohort. Treatment-emergent AEs will be further classified by severity and relationship to study product.
Time frame: 59 days
The Number of Patients Reporting Any Drug-related Treatment-emergent Serious Adverse Event.
To assess the safety and tolerability of visible fluorescent injectate (VFI)™ (employing the FAST PV Technology™) in chronic dialysis patients with extremely reduced or no renal function subjects will be monitored for adverse events and serious adverse events following administration of the first dose of the study drug through the end of the study. Treatment-emergent adverse events will be tabulated by system organ class, preferred term, and cohort. Treatment-emergent AEs will be further classified by severity and relationship to study product.
Time frame: 59 days
The Number of Patients Reporting Any Drug Related Treatment-emergent Adverse Event.
To assess the safety and tolerability of visible fluorescent injectate (VFI)™ (employing the FAST PV Technology™) in chronic dialysis patients with extremely reduced or no renal function subjects will be monitored for adverse events and serious adverse events following administration of the first dose of the study drug through the end of the study. Treatment-emergent adverse events will be tabulated by system organ class, preferred term, and cohort. Treatment-emergent AEs will be further classified by severity and relationship to study product.
Time frame: 59 days