End Stage Renal Disease
Conditions
Brief 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.
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).
Interventions
DEVICEVFI 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.
Sponsors
FAST BioMedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects/patients must meet all inclusion criteria to be eligible for study participation. 1. Males or females ≥ 18 years of age. 2. 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. 3. 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. 4. Males must agree to not donate sperm from screening through 90 days after administration of the last dose of VFI. 5. Subjects/patients must be able to communicate effectively with the study personnel. 6. Patients must be on chronic hemodialysis for \>= 3 months and oliguric defined as \<= 2 urinary voids per day. 7. Patients must have an average interdialytic weight gain of at least 2 kg. 8. Patients must have an A-V dialysis shunt. 9. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Cohort 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
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
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | 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 |
| Cohort 1 | 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 |
| Cohort 1 | Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis | Iohexol PV | 3684 mL | Standard Deviation 954 |
| Cohort 1 | 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 |
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
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | 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 |
| Cohort 1 | 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 |
| Cohort 1 | Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis | Iohexol PV | 3895 mL | Standard Deviation 801 |
| Cohort 1 | 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 |
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
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology | FAST PV Difference | 343 mL | Standard Deviation 376 |
| Cohort 1 | Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology | FAST ISV Difference | 2284 mL | Standard Deviation 680 |
| Cohort 1 | Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology | FAST Total Volume Removed | 2628 mL | Standard Deviation 904 |
| Cohort 1 | Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology | Total Volume removed as measured by UF | 2451 mL | Standard Deviation 604 |
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
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol | Iohexol PV Difference | 340 mL | Standard Deviation 380 |
| Cohort 1 | Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol | Iohexol ISV Difference | 2537 mL | Standard Deviation 2012 |
| Cohort 1 | Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol | Iohexol Total Volume Removed | 2877 mL | Standard Deviation 1940 |
| Cohort 1 | Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol | Total Volume removed measured by UF | 2451 mL | Standard Deviation 604 |
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.
Time frame: 59 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | The Number of Patients Reporting Any Drug Related Treatment-emergent Adverse Event. | 4 Participants |
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.
Time frame: 59 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | The Number of Patients Reporting Any Drug-related Treatment-emergent Serious Adverse Event. | 0 Participants |
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.
Time frame: 59 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | The Number of Patients Reporting Any Treatment-emergent Adverse Event. | 8 Participants |
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.
Time frame: 59 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | The Number of Patients Reporting Any Treatment-emergent Serious Adverse Event. | 3 Participants |