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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44DK093274-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol |
|
| Cohort 2 | Experimental | eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol |
|
| Cohort 3 | Experimental | eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol |
|
| 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 |
|
| Cohort 5 | Experimental | eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function | Cmax = maximum observed concentration occurring at Tmax | 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 |
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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:
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.
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dana V Rizk, M.D | University of Alabama Birmingham, 205-934-9509, drizk@uab.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham, Division of Nephrology | Birmingham | Alabama | 35294-0007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21881552 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | eGFR renal function ≥60 mL/min for normal function |
| FG001 | Cohort 2 | eGFR renal function 30-59 mL/min for stage 3, moderate CKD |
| FG002 | Cohort 3 | eGFR renal function 15-29 mL/min for stage 4, severe CKD |
| FG003 | Cohort 4 | a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI |
| FG004 | Cohort 5 | eGFR renal function ≥60 mL/min for normal function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Estimated GFR (mL/min) ≥60 mL/min/1.73m2 BSA |
| BG001 | Cohort 2 | Estimated GFR (mL/min) 30-59 mL/min/1.73m2 BSA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat subject population | Posted | Number | participants | Baseline through day 22 |
|
Baseline through day 22.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | eGFR renal function ≥60 mL/min for normal function | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Victor Rizk, M.D. | University of Alabama, Birmingham | drizk@uab.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D058186 | Acute Kidney Injury |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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Tmax = time of maximum observed concentration |
| 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | Baseline through day 22 |
| BG002 | Cohort 3 | Estimated GFR (mL/min) 15-29 mL/min/1.73m2 BSA |
| BG003 | Cohort 4 | Estimated GFR (mL/min) sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline |
| BG004 | Cohort 5 | Estimated GFR (mL/min) ≥60 mL/min/1.73m2 BSA |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Cohort 2 |
eGFR renal function 30-59 mL/min for stage 3, moderate CKD |
| OG002 | Cohort 3 | eGFR renal function 15-29 mL/min for stage 4, severe CKD |
| OG003 | Cohort 4 | sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline |
| OG004 | Cohort 5 | eGFR renal function ≥60 mL/min for normal function |
|
|
| Primary | 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. | Intent-to-treat subject population | Posted | Number | adverse events | Baseline through day 22 |
|
|
|
| Secondary | Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function | Cmax = maximum observed concentration occurring at Tmax | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | ng/mL | 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. |
|
|
|
| Secondary | Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function | Tmax = time of maximum observed concentration | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | hr | 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. |
|
|
|
| Secondary | 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) | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | ng∙hr/mL | 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. |
|
|
|
| Secondary | 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) | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | ng∙hr/mL | 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. |
|
|
|
| Secondary | 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) | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | ng∙hr/mL | 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. |
|
|
|
| Secondary | 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 | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | hr | 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. |
|
|
|
| Secondary | 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 | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | mL/m^2 | 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. |
|
|
|
| Secondary | Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function | Vss = volume of distribution at steady state | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | mL/m^2 | 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. |
|
|
|
| Secondary | CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function | CL = total body clearance | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | mL/hr/m^2 | 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. |
|
|
|
| Secondary | 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 | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | [(ng/mL)/(mg/m^2)] | 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. |
|
|
|
| Secondary | 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 | Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4. | Posted | Mean | Standard Deviation | [(ng∙hr/mL)/(mg/m^2)] | 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. |
|
|
|
| Secondary | 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. | The subject in Cohort 4 did not receive Iohexol. One subject in Cohort 5 withdrew from the study before receiving Iohexol. Samples were missing for 1 subject in each of Cohorts 1 and 3. | Posted | Mean | Standard Deviation | mL/min | Baseline through Day 22 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mL | Baseline through day 22 |
|
|
|
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Cohort 2 | eGFR renal function 30-59 mL/min for stage 3, moderate CKD | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Cohort 3 | eGFR renal function 15-29 mL/min for stage 4, severe CKD | 0 | 8 | 0 | 8 | 6 | 8 |
| EG003 | Cohort 4 | a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Cohort 5 | eGFR renal function ≥60 mL/min for normal function | 0 | 8 | 0 | 8 | 5 | 8 |
| Conjunctival Hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctival Oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Miosis | Eye disorders | MedDRA | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema | General disorders | MedDRA | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Tinea Versicolour | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA | Systematic Assessment |
|
| Cardiac Murmur | Investigations | MedDRA | Systematic Assessment |
|
| Liver Palpable Subcostal | Investigations | MedDRA | Systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Number of serious treatment-emergent adverse event |
|
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|
|
|
|
|
|
|
|
|
|
| Iohexol GFR |
|
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| Nadler's Formula Plasma Volume |
|