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

NCT ID: NCT01978314

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Chronic Kidney Disease; Acute Kidney Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1

eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol

Group Type: EXPERIMENTAL

75 mg / 6 mL VFI™

Intervention Type: DEVICE

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Cohort 2

eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol

Group Type: EXPERIMENTAL

75 mg / 6 mL VFI™

Intervention Type: DEVICE

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Cohort 3

eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol

Group Type: EXPERIMENTAL

75 mg / 6 mL VFI™

Intervention Type: DEVICE

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Cohort 4

a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol

Group Type: EXPERIMENTAL

75 mg / 6 mL VFI™

Intervention Type: DEVICE

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Cohort 5

eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol

Group Type: EXPERIMENTAL

75 mg / 6 mL VFI™

Intervention Type: DEVICE

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Interventions

75 mg / 6 mL VFI™

Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

FAST BioMedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana V Rizk, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Alabama Birmingham, 205-934-9509, drizk@uab.edu

Locations

University of Alabama Birmingham, Division of Nephrology

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21881552 (View on PubMed)

Other Identifiers

1R44DK093274-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FAST mGFR -002

Identifier Type: -

Identifier Source: org_study_id