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

NCT01978314 | Completed Results DMC

• 2 other identifiers: FAST mGFR -0021R44DK093274-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function

  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.

  Baseline through day 22

• Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function

  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.

  Baseline through day 22

Secondary Outcomes (13)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (5)

Cohort 1

EXPERIMENTAL

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

Device: 75 mg / 6 mL VFI™

Cohort 2

EXPERIMENTAL

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

Device: 75 mg / 6 mL VFI™

Cohort 3

EXPERIMENTAL

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

Device: 75 mg / 6 mL VFI™

Cohort 4

EXPERIMENTAL

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

Device: 75 mg / 6 mL VFI™

Cohort 5

EXPERIMENTAL

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

Device: 75 mg / 6 mL VFI™

Interventions

75 mg / 6 mL VFI™ 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 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• FAST BioMedical: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama Birmingham, Division of Nephrology

Birmingham, Alabama, 35294-0007, United States

Location

Related Publications (1)

• 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.

  PMID: 21881552 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Too restrictive entry criteria for enrollment into the AKI cohort and the expiry of the clinical VFI led to a decision, in consultation with FDA, to stop the study prematurely.

Results Point of Contact

• Title: Dana Victor Rizk, M.D.
• Organization: University of Alabama, Birmingham

drizk@uab.edu

Study Officials

• Dana V Rizk, M.D

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 7, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Locations

US (1)