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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by FAST BioMedical
Sponsor:
Collaborators:
Information provided by (Responsible Party):
FAST BioMedical
ClinicalTrials.gov Identifier:
NCT01978314
First received: October 25, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Chronic Kidney Disease
Acute Kidney Injury
Device: 75 mg / 6 mL VFI™
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by FAST BioMedical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
75 mg / 6mL VFI™ and 5mL of Iohexol

4 Cohorts

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™

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

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 anitcoagulants
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978314

Contacts
Contact: Teresa Chacana, MSN, RN 205-934-7649 tchacana@uab.edu

Locations
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    tchacana@uab.edu   
Principal Investigator: Dana Rizk, MD         
Sponsors and Collaborators
FAST BioMedical
Investigators
Principal Investigator: Dana V Rizk, M.D University of Alabama Birmingham, 205-934-9509, drizk@uab.edu
  More Information

Publications:
Responsible Party: FAST BioMedical
ClinicalTrials.gov Identifier: NCT01978314     History of Changes
Other Study ID Numbers: FAST mGFR -002, 1R44DK093274-01
Study First Received: October 25, 2013
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by FAST BioMedical:
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

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014