Clinical trial NCT01978314: FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Acute Kidney Injury
Keywords: Chronic Kidney Disease
Acute Kidney Injury
AKI
CKD
Plasma Volume
GFR
Glomerular Filtration Rate
Blood volume
mGFR
measured GFR
kidney biomarker
renal disease
renal biomarker
Renal function
kidney function
organ function
kidney monitor
kidney device
Lead sponsor: FAST BioMedical
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-11-07
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study was a prospective, open-label, single site study designed to evaluate the safety of the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of renal impairment and hemodynamically stable AKI.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria for Groups 1-3:

* Female subjects: women must have a negative urine pregnancy test at screening and before dosing on Visit 2 and be either confirmed by the Investigator to be infertile or using a reliable method of contraception Male subjects: reproductively active men must agree to either practice abstinence or utilize adequate contraception.
* Ages 19 to 75
* Subject's screening must fall into one of the available categories of estimated glomerular filtration rate (eGFR) renal function: ≥ 60 mL/min for stage normal function; 30-59 mL/min for stage 3, moderate CKD; 15-29 mL/min for stage 4, severe CKD,
* Patients must not be on inotropes or vasopressors, and must be absent of significant hemodynamic instabilities.
* Patients must have ceased use of the following:

  * nonsteroidal anti-inflammatory drugs - 6 days prior,
  * herbal supplements - 6 days prior to testing and
  * cimetidine and trimethoprim - 14 days prior to testing.
* Ability to comply with study conditions

Inclusion Criteria for Group 4:

- Female subjects; women must have a negative urine pregnancy test at screening and before dosing on Visit 2 and be either confirmed by the Investigator to be infertile or using a reliable method of contraception.

Male subjects: reproductively active men must agree to either practice abstinence or utilize adequate contraception.

* Ages 19 to 75
* For cohort 4: patients diagnosed with \[either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI\]
* Patients must not be on inotropes or vasopressors, and must be absent of significant hemodynamic instabilities.
* Patients must be without evidence of clinically significant liver dysfunction
* Ability to comply with study conditions

Exclusion Criteria for Groups 1-3:

* Positive history of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to sulfa, iodine, dyes, shellfish, isotopes or dextran molecules
* Previous history of nephrectomy or kidney transplant
* A body weight below 40kg
* A body mass index \<17 or \>40
* Subjects using Coumadin (Warfarin) who have an INR \>4 at Screening or pre-dose on Visit 2
* Past history of liver disease or screening Liver Function tests which exceed 1.5 times the upper limit of normal or an albumin of \< 2mg/dl.
* Clinically significant illness within 4 weeks or a clinically significant infection within 4 weeks of screening
* Received blood, donated blood, have clinically significant on-going bleeding, changing haemoglobin, or experienced significant blood loss within 2 weeks of dosing
* Subjects with significant abnormal findings upon physical examination, vital signs, ECG, or clinical laboratory results at Screening
* Subjects with a supine blood pressure after resting for at least 5 minutes outside the 90-145 (systolic) or mmHg or 50-95 mmHg (diastolic) range
* Subjects with a supine (ECG) heart rate outside 45-105 beats/min after resting for at least 5 minutes.
* Subjects with a known or suspected history of drug or alcohol misuse within 6 months prior to screening, subjects who have consumed alcohol within 48 hours of dosing, or subjects who the Investigator believes to be unfit to participate in the study due to abuse of illegal or controlled substances.
* Subjects who had a positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb) screen.
* Subjects who have been diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV).
* Subjects who participated in another clinical trial less than 1 month prior to dosing, or who are currently enrolled in another clinical trial.
* Subjects who have any condition that:

  * Would make him/her, in the opinion of the Investigator, unsuitable for the study
  * Whose condition is likely to deteriorate
  * Who, in the opinion of the Investigator, is not likely to complete the study for any reason

Exclusion Criteria for Group 4:

* Positive history of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to sulfa, iodine, dyes, shellfish, isotopes or dextran molecules
* Previous history of nephrectomy or kidney transplant
* A body weight below 40kg
* A body mass index \<17 or \>40
* Current use of prescribed anticoagulants
* Past history of liver disease or screening Liver Function tests which exceed 1.5 times the upper limit of normal or an albumin of \< 2mg/dl.
* Received blood, donated blood, have clinically significant on-going bleeding, changing haemoglobin, or experienced significant blood loss within 2 weeks of dosing
* Subjects with a supine blood pressure after resting for at least 5 minutes outside the 90-145 (systolic) or mmHg or 50-95 mmHg (diastolic) range
* Subjects with a supine (ECG) heart rate outside 45-105 beats/min after resting for at least 5 minutes.
* Subjects with a known or suspected history of drug or alcohol abuse within 6 months prior to admission, who have a positive drug test or alcohol test, or who have consumed alcohol within 24 of testing
* Subjects who had a positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb) screen.
* Subjects who have been diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV).
* Subjects who participated in another clinical trial less than 1 month prior to dosing, or who are currently enrolled in another clinical trial.
* Subjects who have any condition that:

  * Would make him/her, in the opinion of the Investigator, unsuitable for the study
  * Whose condition is likely to deteriorate
  * Who, in the opinion of the Investigator, is not likely to complete the study for any reason

Primary outcomes:
measure: Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: Baseline through day 22
measure: Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: Baseline through day 22
Secondary outcomes:
measure: Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
timeFrame: 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.
measure: To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.
timeFrame: Baseline through Day 22
measure: To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.
timeFrame: Baseline through day 22
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham, Division of Nephrology
state: Alabama
Study officials:
affiliation: University of Alabama Birmingham, 205-934-9509, drizk@uab.edu
name: Dana V Rizk, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang E, Meier DJ, Sandoval RM, Von Hendy-Willson VE, Pressler BM, Bunch RM, Alloosh M, Sturek MS, Schwartz GJ, Molitoris BA. A portable fiberoptic ratiometric fluorescence analyzer provides rapid point-of-care determination of glomerular filtration rate in large animals. Kidney Int. 2012 Jan;81(1):112-7. doi: 10.1038/ki.2011.294. Epub 2011 Aug 31.