Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chron… (NCT04733664) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients
United States10 participantsStarted 2020-10-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Pre-dialysis
Timeframe: 1 day
2
Evaluate Plasma Volume (PV) and Interstitial Volume (ISV) Using the FAST PV Technology and Iohexol in Patients on Chronic Dialysis Post-dialysis
Timeframe: 1 day
3
Evaluate the Difference in ISV and PV Pre- and Post Dialysis by the FAST PV Technology
Timeframe: 1 day
4
Evaluate the Difference of ISV and PV Pre- and Post Dialysis by Iohexol
Timeframe: 1 day
5
The Number of Patients Reporting Any Treatment-emergent Adverse Event.
Timeframe: 59 days
6
The Number of Patients Reporting Any Treatment-emergent Serious Adverse Event.
Timeframe: 59 days
7
The Number of Patients Reporting Any Drug-related Treatment-emergent Serious Adverse Event.
. Subjects/patients must be able to communicate effectively with the study personnel.
. 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.
Exclusion criteria
. 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.
Timeframe: 59 days
8
The Number of Patients Reporting Any Drug Related Treatment-emergent Adverse Event.