FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
Chronic Kidney Disease
Acute Kidney Injury
Device: 75 mg / 6 mL VFI™
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Single-Center Prospective Study Evaluating the FAST Measured Glomerular Filtration Rate (mGFR) Test™ in Adults With Preserved Kidney Function and Impaired Kidney Function With Comparison to Iohexol Clearance Methods|
- Assess the safety of the VFI™ in patients with varying degrees of kidney function. [ Time Frame: Safety Assessments from Baseline through Days 1, 2, 4, 8, 15, 22 ] [ Designated as safety issue: No ]
- Comparison of kidney function determined by the results of the FAST VFI™ to existing clinical and research standards. [ Time Frame: Baseline change in kidney function by study subjects compared to existing measurements used to determine kidney function. ] [ Designated as safety issue: No ]Comparison of kidney function determined by the results of the FAST VFI™ to that indicated by existing measurements including Iohexol clearance and biomarkers including cystatin C, blood urea nitrogen, and eGFR.
- Evaluate the PK profile of the VFI™ in patients wtih varying degree of kidney function [ Time Frame: PK profile will be collected pre and post dose at Day 2. Post dose on Days 4, 8, 15, 22. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
75 mg / 6mL VFI™ and 5mL of Iohexol
Cohort 1 - 8 patients with eGFR > 60 mL/min receiving 75 mg / 1.5 mL VFI™ Cohort 2 - 8 patients with eGFR 30 mL/min to 59 mL/min receiving 75 mg / 6mL VFI™ Cohort 3 - 8 patients with eGFR 15 mL/min to 29 mL/min receiving 75 mg / 6mL VFI™ Cohort 4 - 6 RIFLE stage "I" or AKIN stage 2 patients with a ≥2-fold increase in serum Creatinine (sCR) or >50% decrease in eGFR compared to baseline receiving 75 mg / 6mL VFI™ and 5 mL of Iohexol.
Device: 75 mg / 6 mL VFI™
75 mg / 6 mL VFI™
A rapid and accurate measurement of glomerular filtration rate (GFR) is important in acute kidney injury (AKI) and chronic kidney disease (CKD) for assessment of impairment, diagnosis, and prompt treatment. FAST BioMedical is an emerging technology company whose mission is to quantify clinically meaning ful physiological parameters that have been difficult or impossible to measure. GFR is the most clinically relevant metric for understanding renal function, as it is the rate by which the kidney is able to filter waste products in the bloodstream. The FAST mGFR is for direct measurement of GFR that relies on reading the ratio of fluorescent markers attached to different size dextran molecules introduced into the bloodstream. The test is intended as an adjunct to current methods utilized to assess kidney function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978314
|Contact: Teresa Chacana, MSN, RNemail@example.com|
|United States, Alabama|
|University of Alabama Birmingham, Division of Nephrology||Recruiting|
|Birmingham, Alabama, United States, 35294-0007|
|Contact: Teresa Chacana, MSN, RN 205-934-7649 firstname.lastname@example.org|
|Principal Investigator: Dana Rizk, MD|
|Principal Investigator:||Dana V Rizk, M.D||University of Alabama Birmingham, 205-934-9509, email@example.com|