FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.

Not Applicable

Completed

Conditions: Chronic Kidney Disease
Acute Kidney Injury

Interventions: Device: 75 mg / 6 mL VFI™

Registration Number: NCT01978314

Lead Sponsor: FAST BioMedical

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	75 mg / 6 mL VFI™	eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
Cohort 2	75 mg / 6 mL VFI™	eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
Cohort 3	75 mg / 6 mL VFI™	eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
Cohort 4	75 mg / 6 mL VFI™	a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
Cohort 5	75 mg / 6 mL VFI™	eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	Baseline through day 22	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.
Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	Baseline through day 22	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.

Secondary Outcome Measures

Name	Time	Method
Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	Vss = volume of distribution at steady state
To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.	Baseline through day 22	This analysis will compare estimates of plasma volume derived by FAST's plasma volume method with that derived using the conventional Nadler's Formula for plasma volume.
Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	Cmax = maximum observed concentration occurring at Tmax
Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	Tmax = time of maximum observed concentration
AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	AUCall = area under the concentration-time curve (time 0 to last scheduled sample)
AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	AUClast = area under the concentration-time curve (time 0 to last sample with a quantifiable measurable concentration)
T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	T1/2 = terminal half-life = ln(2)/λz
Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	Cmax/Dose = maximum observed concentration occurring at Tmax/Dose
To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.	Baseline through Day 22	This analysis will compare estimates of kidney function derived from the results of FAST VFI™ to those derived through conventional Iohexol clearance methods.
AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	AUCinf = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)
Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	Vz = volume of distribution based upon terminal phase
CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	CL = total body clearance
AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.	AUCinf/Dose = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)/Dose