Trial Outcomes & Findings for Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients (NCT NCT04733664)
NCT ID: NCT04733664
Last Updated: 2023-02-08
Results Overview
To measure quantitatively the ISV and PV of patients pre dialysis using the FAST PV Technology and iohexol measurement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 day
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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8 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
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Age, Continuous
|
58.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 dayTo measure quantitatively the ISV and PV of patients pre dialysis using the FAST PV Technology and iohexol measurement
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
FAST PV
|
3869 mL
Standard Deviation 805
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|
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
FAST ISV
|
9152 mL
Standard Deviation 1701
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
Iohexol PV
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3895 mL
Standard Deviation 801
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
Iohexol ISV
|
19057 mL
Standard Deviation 3376
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PRIMARY outcome
Timeframe: 1 dayTo measure quantitatively the ISV and PV of patients post dialysis using FAST PV Technology and the iohexol measurement
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
|
|---|---|
|
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
Iohexol ISV
|
16770 mL
Standard Deviation 4409
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
FAST PV
|
3615 mL
Standard Deviation 963
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
FAST ISV
|
7078 mL
Standard Deviation 1816
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Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
Iohexol PV
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3684 mL
Standard Deviation 954
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PRIMARY outcome
Timeframe: 1 dayDirectly compare quantitative difference of ISV and PV measured by the FAST PV Technology to the volume removed during dialysis
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
FAST PV Difference
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343 mL
Standard Deviation 376
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Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
FAST Total Volume Removed
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2628 mL
Standard Deviation 904
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Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
Total Volume removed as measured by UF
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2451 mL
Standard Deviation 604
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Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
FAST ISV Difference
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2284 mL
Standard Deviation 680
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PRIMARY outcome
Timeframe: 1 dayDirectly compare quantitative difference of ISV and PV measured by the Iohexol measurement to the volume removed during dialysis
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Iohexol Total Volume Removed
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2877 mL
Standard Deviation 1940
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Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Iohexol PV Difference
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340 mL
Standard Deviation 380
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Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Iohexol ISV Difference
|
2537 mL
Standard Deviation 2012
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Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Total Volume removed measured by UF
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2451 mL
Standard Deviation 604
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PRIMARY outcome
Timeframe: 59 daysTo 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.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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The Number of Patients Reporting Any Treatment-emergent Adverse Event.
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8 Participants
|
PRIMARY outcome
Timeframe: 59 daysTo 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.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
|
|---|---|
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The Number of Patients Reporting Any Treatment-emergent Serious Adverse Event.
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3 Participants
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PRIMARY outcome
Timeframe: 59 daysTo 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.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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The Number of Patients Reporting Any Drug-related Treatment-emergent Serious Adverse Event.
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0 Participants
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PRIMARY outcome
Timeframe: 59 daysTo 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.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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The Number of Patients Reporting Any Drug Related Treatment-emergent Adverse Event.
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4 Participants
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Adverse Events
Cohort 1
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Gastrointestinal disorders
Gastrointestinal Bleed
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Vascular disorders
Volume Overload
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20.0%
2/10 • Number of events 2 • Enrollment through Discharge, possibly up to 59 days.
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Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.
VFI using the FAST PV Technology: 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.
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|---|---|
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Gastrointestinal disorders
Nausea
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Infections and infestations
Viral Syndrome
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Musculoskeletal and connective tissue disorders
Leg Pain
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Respiratory, thoracic and mediastinal disorders
Cough
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Skin and subcutaneous tissue disorders
Pruritus
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20.0%
2/10 • Number of events 2 • Enrollment through Discharge, possibly up to 59 days.
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Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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General disorders
Dizziness
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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General disorders
Clotted Fistula
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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General disorders
Fistula Pseudoaneurysm
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Vascular disorders
Volume Overload
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10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Investigations
Elevated CPK
|
10.0%
1/10 • Number of events 1 • Enrollment through Discharge, possibly up to 59 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60