Chronic Kidney DiseaseNCT01978314
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
A study testing 75 mg / 6 mL VFI™ in people with Chronic Kidney Disease and Acute Kidney Injury, run by FAST BioMedical at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Acute Kidney Injury
- What is being tested?
- 75 mg / 6 mL VFI™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
Show all 36Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham, Division of Nephrology
Birmingham, Alabama, 35294-0007
About this study
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
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).
Read the 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
- Being tested
- 75 mg / 6 mL VFI™
- 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
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: 75 mg / 6 mL VFI™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through day 22
Secondary outcomes (13)
Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Cmax = maximum observed concentration occurring at Tmax
Measured: 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
Tmax = time of maximum observed concentration
Measured: 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
AUClast = area under the concentration-time curve (time 0 to last sample with a quantifiable measurable concentration)
Measured: 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
AUCall = area under the concentration-time curve (time 0 to last scheduled sample)
Measured: 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
AUCinf = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)
Measured: 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, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
T1/2 = terminal half-life = ln(2)/λz
Measured: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Vz = volume of distribution based upon terminal phase
Measured: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Vss = volume of distribution at steady state
Measured: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
CL = total body clearance
Measured: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Cmax/Dose = maximum observed concentration occurring at Tmax/Dose
Measured: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
AUCinf/Dose = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)/Dose
Measured: 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.
To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.
This analysis will compare estimates of kidney function derived from the results of FAST VFI™ to those derived through conventional Iohexol clearance methods.
Measured: Baseline through Day 22
To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.
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.
Measured: Baseline through day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- FAST BioMedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Dana V Rizk, M.D, Principal investigator, University of Alabama Birmingham, 205-934-9509, drizk@uab.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978314
- Sponsor's protocol ID
- FAST mGFR -002
- Other IDs
- 1R44DK093274-01
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2013
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21881552
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01978314
- Acronym / sponsor ID
- FAST mGFR -002
- Conditions
- Chronic Kidney Disease, Acute Kidney Injury
- Keywords
- Chronic Kidney Disease, Acute Kidney Injury, AKI, CKD, Plasma Volume, GFR, Glomerular Filtration Rate, Blood volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- FAST BioMedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: 75 mg / 6 mL VFI™eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol |
| Cohort 2 | Experimental | Device: 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 | Experimental | Device: 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 | Experimental | Device: 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 | Experimental | Device: 75 mg / 6 mL VFI™eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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.
13 secondary outcomes
Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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 of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function
Time frame: 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.
To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.
Time frame: Baseline through Day 22
To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.
Time frame: Baseline through day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21881552Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana V Rizk, M.D principal investigator
University of Alabama Birmingham, 205-934-9509, drizk@uab.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 75 mg / 6 mL VFI™ in people with Chronic Kidney Disease and Acute Kidney Injury, run by FAST BioMedical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function (time frame: Baseline through day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.