End Stage Renal DiseaseNCT04733664

Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients

A study testing VFI using the FAST PV Technology in people with End Stage Renal Disease, run by FAST BioMedical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: VFI using the FAST PV Technology
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2020to 9 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects/patients must meet all inclusion criteria to be eligible for study participation.
Males or females ≥ 18 years of age.
Females must be of non-childbearing potential (eg, postmenopausal [defined cessation of regular menstrual periods for at least 1 year confirmed by age => 60 or surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation [documentation required]) or be using a medically acceptable form of birth control (a barrier method, intrauterine device, or hormonal contraception) from screening through 30 days after administration of the last dose of VFI.
Males who are sexually active and whose partners are females of childbearing potential must agree to practice abstinence or use condoms from screening through 90 days after administration of the last dose of VFI, and their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of VFI.
Males must agree to not donate sperm from screening through 90 days after administration of the last dose of VFI.
Subjects/patients must be able to communicate effectively with the study personnel.

Show all 31Show fewer

Patients must be on chronic hemodialysis for >= 3 months and oliguric defined as <= 2 urinary voids per day.
Patients must have an average interdialytic weight gain of at least 2 kg.
Patients must have an A-V dialysis shunt.
Patients must have a functioning A-V dialysis shunt, either fistula or graft.
Exclusion Criteria Subjects/patients will not be eligible for study participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the investigator if they develop any of the exclusion criteria during the study.
Subject is a pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
History or presence of conditions which, in the judgment of the investigator, are known to interfere with the distribution, metabolism, or excretion of drugs
History or presence of conditions that may place the subject/patient at increased risk as determined by the investigator.
History of surgery or major trauma within 12 weeks of screening or surgery planned within 4 weeks of the study, including during study participation.
Has taken other investigational drugs within 30 days or 5 half-lives of the investigational drug's PK, PD, or biological activity, whichever is longer, prior to first dose of VFI in this study.
Prior exposure to VFI or known allergy or hypersensitivity to dextran, 5-aminofluorescein dye, or 2-sulfohexamine rhodamine dye.
History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to iodine, dyes, shellfish, isotopes, or dextran molecules.
Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 4 weeks prior to study participation.
Presence of significant hemodynamic instabilities defined as systolic BP <100 on dialysis requiring saline infusion in the past 4 weeks.
Presence of ascites and/or 4+ anasarca.
Any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
Involved in the planning or conduct of this study.
Unwilling or unlikely to comply with the requirements of the study.
Clinically significant ongoing bleeding, changing hemoglobin, or experienced significant blood loss within the last 4 weeks.
Had a PRBC transfusion in the prior 2 weeks
Use of midodrine.
Any other condition or prior therapy that, in the investigator's opinion, is likely to deteriorate during study participation
Subjects suffering from significant non-cardiac diseases of other organ systems (e. g. Malignancies, significant neurological diseases).
Subject has a psychiatric disease or a history of illicit drug use that would prohibit them from complying with study requirements.
Use of hemodialysis catheter as primary vascular access for hemodialysis

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients With Extremely Reduced or No Kidney Function

Read the detailed description

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).

Conditions: End Stage Renal Disease
Being tested: VFI using the FAST PV Technology
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VFI using the FAST PV TechnologyDevice
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.

Study groups in NCT04733664
Study group	Role	What they receive
Cohort 1	Experimental	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. Receives: Device: VFI using the FAST PV Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 59 days
The Number of Patients Reporting Any 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.
Measured: 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.
Measured: 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.
Measured: 59 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 20209 Mar 2021

First posted2 Feb 2021
Study start29 Oct 2020
Primary completion9 Mar 2021
Study completion9 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04733664
Sponsor's protocol ID: 2008193898
Status last verified: Jan 2023
First submitted: 1 Sep 2020
Last updated: 8 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients With Extremely Reduced or No Kidney Function
ClinicalTrials.gov ID: NCT04733664
Acronym / sponsor ID: 2008193898
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: FAST BioMedicalIndustry (pharma, biotech, devices)
Study start: 29 Oct 2020 (actual)
Primary completion: 9 Mar 2021 (actual)
Study completion: 9 Mar 2021 (actual)
First posted: 2 Feb 2021 (actual)
Results: Posted 1 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cohort 1	Experimental	Device: VFI using the FAST PV TechnologyPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Subjects/patients must meet all inclusion criteria to be eligible for study participation.
Males or females ≥ 18 years of age.
Females must be of non-childbearing potential (eg, postmenopausal [defined cessation of regular menstrual periods for at least 1 year confirmed by age => 60 or surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation [documentation required]) or be using a medically acceptable form of birth control (a barrier method, intrauterine device, or hormonal contraception) from screening through 30 days after administration of the last dose of VFI.
Males who are sexually active and whose partners are females of childbearing potential must agree to practice abstinence or use condoms from screening through 90 days after administration of the last dose of VFI, and their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of VFI.
Males must agree to not donate sperm from screening through 90 days after administration of the last dose of VFI.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VFI using the FAST PV TechnologyThe 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.	Device	Cohort 1

Primary outcome

Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
Time frame: 1 day
To measure quantitatively the ISV and PV of patients pre dialysis using the FAST PV Technology and iohexol measurement
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
Time frame: 1 day
To measure quantitatively the ISV and PV of patients post dialysis using FAST PV Technology and the iohexol measurement
Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
Time frame: 1 day
Directly compare quantitative difference of ISV and PV measured by the FAST PV Technology to the volume removed during dialysis
Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Time frame: 1 day
Directly compare quantitative difference of ISV and PV measured by the Iohexol measurement to the volume removed during dialysis
The Number of Patients Reporting Any Treatment-emergent Adverse Event.
Time frame: 59 days
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.
The Number of Patients Reporting Any Treatment-emergent Serious Adverse Event.
Time frame: 59 days
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.
The Number of Patients Reporting Any Drug-related Treatment-emergent Serious Adverse Event.
Time frame: 59 days
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.
The Number of Patients Reporting Any Drug Related Treatment-emergent Adverse Event.
Time frame: 59 days
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.

Results and safety

Results posted to the registry on 1 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	10	10

Primary outcome: Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis

Time frame: 1 day. Mean (Standard Deviation). Unit: mL

Measure	Cohort 1 n = 10
FAST PV	3869 (805)
FAST ISV	9152 (1701)
Iohexol PV	3895 (801)
Iohexol ISV	19057 (3376)

Primary outcome: Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis

Time frame: 1 day. Mean (Standard Deviation). Unit: mL

Measure	Cohort 1 n = 9
FAST PV	3615 (963)
FAST ISV	7078 (1816)
Iohexol PV	3684 (954)
Iohexol ISV	16770 (4409)

Primary outcome: Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology

Time frame: 1 day. Mean (Standard Deviation). Unit: mL

Measure	Cohort 1 n = 9
FAST PV Difference	343 (376)
FAST ISV Difference	2284 (680)
FAST Total Volume Removed	2628 (904)
Total Volume removed as measured by UF	2451 (604)

Primary outcome: Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol

Time frame: 1 day. Mean (Standard Deviation). Unit: mL

Measure	Cohort 1 n = 9
Iohexol PV Difference	340 (380)
Iohexol ISV Difference	2537 (2012)
Iohexol Total Volume Removed	2877 (1940)
Total Volume removed measured by UF	2451 (604)

Adverse events

Time frame: Enrollment through Discharge, possibly up to 59 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	3 of 10 (30%)	8 of 10 (80%)	0 of 10

Limitations and caveats (from the sponsor): One patient's PV and ISV were not evaluable post dialysis due to a sampling error.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VFI using the FAST PV Technology in people with End Stage Renal Disease, run by FAST BioMedical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 2 Nov 2026.