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NCT03095391 · ClinicalTrials.gov registry record
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™
A clinical trial of Acute Kidney Injury and Kidney Diseases, sponsored by FAST BioMedical.
- Completed
- Registry status
- 32
- Enrollment target
- 2
- Study locations
NCT03095391: Completed study of Acute Kidney Injury and Kidney Diseases, sponsored by FAST BioMedical.
NCT03095391 is a study of Acute Kidney Injury and Kidney Diseases that has completed, run by FAST BioMedical. The registered enrollment target is 32 participants, below the 2,331-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095391, a study of Acute Kidney Injury and Kidney Diseases, has completed, sponsored by FAST BioMedical.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.
Primary Outcome
* Subjects will be monitored for AEs from administration of the first dose of study drug through the end of study visit * Abnormal clinical laboratory tests, physical examination findings, 12-lead electrocardiograms (ECGs), and vital signs including pulse oximetry that (1) are considered clinically significant initially and on confirmation, (2) require a subject to be discontinued from the study, (3) require a subject to receive treatment, or (4) require a change or discontinuation from the stud
Conditions Studied
Interventions
- DEVICE VFI
- DEVICE Iohexol
Study Locations (2)
Alabama
- University of Alabama Birmingham, Division of Nephrology - Birmingham
Texas
- ICON Early Phase Services, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2017-09-20 |
What the finished NCT03095391 record still lists
NCT03095391 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 2,331-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which VFI is the first listed.
NCT03095391 reports a single indexed study location in Alabama, Texas.
Frequently Asked Questions
What is clinical trial NCT03095391 about?
NCT03095391 is a clinical study titled "The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™". This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.
What is the current status of trial NCT03095391?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2017-06-13. Estimated completion is 2017-09-20.
What conditions does trial NCT03095391 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Kidney Diseases, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases.
What interventions are being tested in trial NCT03095391?
The interventions under investigation include: VFI (DEVICE), Iohexol (DEVICE).
Who is sponsoring clinical trial NCT03095391?
This trial is sponsored by FAST BioMedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03095391 being conducted?
This trial has 2 study locations across Alabama, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03095391's enrollment target sits among peer trials
32 63rd of 74 higher than 11 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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