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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VFI using the FAST PV Technology | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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. | 59 days |
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Inclusion Criteria:
Subjects/patients must meet all inclusion criteria to be eligible for study participation.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mL | 1 day |
|
Enrollment through Discharge, possibly up to 59 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Bleed | Gastrointestinal disorders | MedDRA | Systematic Assessment | GI Bleed, not drug related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
One patient's PV and ISV were not evaluable post dialysis due to a sampling error.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arjun D. Sinha | Richard L. Roudebush VA Medical Center | --- | adsinha@iu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2020 | Mar 1, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2020 | Jan 10, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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. |
| 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. | 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. | 59 days |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | mL | 1 day |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | mL | 1 day |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | mL | 1 day |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 59 days |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 59 days |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 59 days |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 59 days |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 8 |
| 10 |
|
| Volume Overload | Vascular disorders | MedDRA | Systematic Assessment | Not drug related |
|
| Viral Syndrome | Infections and infestations | MedDRA | Systematic Assessment |
|
| Leg Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Dizziness | General disorders | MedDRA | Systematic Assessment |
|
| Clotted Fistula | General disorders | MedDRA | Systematic Assessment |
|
| Fistula Pseudoaneurysm | General disorders | MedDRA | Systematic Assessment |
|
| Volume Overload | Vascular disorders | MedDRA | Systematic Assessment |
|
| Elevated CPK | Investigations | MedDRA | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Iohexol ISV |
|
| Title | Measurements |
|---|---|
|
| Total Volume removed as measured by UF |
|
| Title | Measurements |
|---|---|
|
| Total Volume removed measured by UF |
|