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The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™
NCT03095391 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095391
The ClinicalTrials.gov registry entry for NCT03095391 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FAST BioMedical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03095391 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03095391?
The interventions under investigation include: VFI (DEVICE), Iohexol (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03095391?
This trial is sponsored by FAST BioMedical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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