Trial Outcomes & Findings for FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients. (NCT NCT01978314)

NCT ID: NCT01978314

Last Updated: 2017-12-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline through day 22
• Results posted on: 2017-12-12

Participant Flow

Participant milestones

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI	Cohort 5 eGFR renal function ≥60 mL/min for normal function
Overall Study STARTED	8	8	8	1	8
Overall Study COMPLETED	8	8	8	1	8
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cohort 1 n=8 Participants Estimated GFR (mL/min) ≥60 mL/min/1.73m2 BSA	Cohort 2 n=8 Participants Estimated GFR (mL/min) 30-59 mL/min/1.73m2 BSA	Cohort 3 n=8 Participants Estimated GFR (mL/min) 15-29 mL/min/1.73m2 BSA	Cohort 4 n=1 Participants Estimated GFR (mL/min) sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants Estimated GFR (mL/min) ≥60 mL/min/1.73m2 BSA	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants	33 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	27.9 years STANDARD_DEVIATION 5.19 • n=5 Participants	56.6 years STANDARD_DEVIATION 7.03 • n=7 Participants	55.6 years STANDARD_DEVIATION 17.74 • n=5 Participants	63.0 years STANDARD_DEVIATION 0 • n=4 Participants	31.8 years STANDARD_DEVIATION 14.10 • n=21 Participants	46.98 years STANDARD_DEVIATION 7.78 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants	25 Participants n=8 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants	33 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline through day 22

Population: Intent-to-treat subject population

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.

Outcome measures

Measure	Cohort 1 n=8 Participants eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 n=1 Participants sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function	3 participants	4 participants	6 participants	1 participants	5 participants

PRIMARY outcome

Timeframe: Baseline through day 22

Population: Intent-to-treat subject population

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.

Outcome measures

Measure	Cohort 1 n=8 Participants eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 n=1 Participants sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function Number of treatment-emergent adverse events	5 adverse events	6 adverse events	9 adverse events	3 adverse events	14 adverse events
Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function Number of serious treatment-emergent adverse event	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: 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.

Population: 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.

Cmax = maximum observed concentration occurring at Tmax

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	8949 ng/mL Standard Deviation 1350	9725 ng/mL Standard Deviation 1847	—	9336 ng/mL Standard Deviation 1553
Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	9569 ng/mL Standard Deviation 1809	10906 ng/mL Standard Deviation 2307	—	12663 ng/mL Standard Deviation 2680

SECONDARY outcome

Timeframe: 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.

Population: 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.

Tmax = time of maximum observed concentration

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	0.281 hr Standard Deviation 0.0884	0.273 hr Standard Deviation 0.0947	—	0.25 hr Standard Deviation 0
Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	4.33 hr Standard Deviation 8.16	0.335 hr Standard Deviation 0.27	—	2.64 hr Standard Deviation 3.16

SECONDARY outcome

Timeframe: 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.

Population: 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.

AUClast = area under the concentration-time curve (time 0 to last sample with a quantifiable measurable concentration)

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	37594 ng∙hr/mL Standard Deviation 12938	74317 ng∙hr/mL Standard Deviation 27069	—	18681 ng∙hr/mL Standard Deviation 2066
AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	1701850 ng∙hr/mL Standard Deviation 276886	1642731 ng∙hr/mL Standard Deviation 443350	—	1710348 ng∙hr/mL Standard Deviation 355518

SECONDARY outcome

Timeframe: 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.

Population: 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.

AUCall = area under the concentration-time curve (time 0 to last scheduled sample)

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	42462 ng∙hr/mL Standard Deviation 12128	80058 ng∙hr/mL Standard Deviation 25030	—	19924 ng∙hr/mL Standard Deviation 2441
AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	1701850 ng∙hr/mL Standard Deviation 276886	1642731 ng∙hr/mL Standard Deviation 443350	—	1710348 ng∙hr/mL Standard Deviation 355518

SECONDARY outcome

Timeframe: 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.

Population: 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.

AUCinf = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	38844 ng∙hr/mL Standard Deviation 12960	76554 ng∙hr/mL Standard Deviation 26430	—	19127 ng∙hr/mL Standard Deviation 2107
AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	1821296 ng∙hr/mL Standard Deviation 302728	1756948 ng∙hr/mL Standard Deviation 503557	—	1755162 ng∙hr/mL Standard Deviation 366071

SECONDARY outcome

Timeframe: 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.

Population: 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.

T1/2 = terminal half-life = ln(2)/λz

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	123 hr Standard Deviation 38.9	125 hr Standard Deviation 32.8	—	90.9 hr Standard Deviation 10.4
T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	9.48 hr Standard Deviation 4.28	18.3 hr Standard Deviation 12.6	—	5.64 hr Standard Deviation 1.23

SECONDARY outcome

Timeframe: 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.

Population: 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.

Vz = volume of distribution based upon terminal phase

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	8343 mL/m^2 Standard Deviation 1733	7907 mL/m^2 Standard Deviation 2613	—	11451 mL/m^2 Standard Deviation 3430
Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	1177 mL/m^2 Standard Deviation 293	1384 mL/m^2 Standard Deviation 644	—	1018 mL/m^2 Standard Deviation 208

SECONDARY outcome

Timeframe: 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.

Population: 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.

Vss = volume of distribution at steady state

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	5430 mL/m^2 Standard Deviation 781	5464 mL/m^2 Standard Deviation 1425	—	6599 mL/m^2 Standard Deviation 4289
Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	1039 mL/m^2 Standard Deviation 299	1132 mL/m^2 Standard Deviation 274	—	937 mL/m^2 Standard Deviation 181

SECONDARY outcome

Timeframe: 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.

Population: 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.

CL = total body clearance

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	677 mL/hr/m^2 Standard Deviation 190	143 mL/hr/m^2 Standard Deviation 39.5	—	1404 mL/hr/m^2 Standard Deviation 242
CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	6.82 mL/hr/m^2 Standard Deviation 1.26	7.65 mL/hr/m^2 Standard Deviation 2.67	—	7.74 mL/hr/m^2 Standard Deviation 1.14

SECONDARY outcome

Timeframe: 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.

Population: 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.

Cmax/Dose = maximum observed concentration occurring at Tmax/Dose

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	369 [(ng/mL)/(mg/m^2)] Standard Deviation 43.1	73.8 [(ng/mL)/(mg/m^2)] Standard Deviation 18.7	—	354 [(ng/mL)/(mg/m^2)] Standard Deviation 55
Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	787 [(ng/mL)/(mg/m^2)] Standard Deviation 125	877 [(ng/mL)/(mg/m^2)] Standard Deviation 135	—	956 [(ng/mL)/(mg/m^2)] Standard Deviation 197

SECONDARY outcome

Timeframe: 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.

Population: 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.

AUCinf/Dose = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)/Dose

Outcome measures

Measure	Cohort 1 eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD001	—	1641 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 590	1071 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 34.6	—	731 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 129
AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function FD003	—	150220 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 22006	141337 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 35933	—	131599 [(ng∙hr/mL)/(mg/m^2)] Standard Deviation 19656

SECONDARY outcome

Timeframe: Baseline through Day 22

Population: 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.

This analysis will compare estimates of kidney function derived from the results of FAST VFI™ to those derived through conventional Iohexol clearance methods.

Outcome measures

Measure	Cohort 1 n=8 Participants eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 n=1 Participants sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods. VFI mGFR	83.20 mL/min Standard Deviation 16.967	42.89 mL/min Standard Deviation 5.810	30.17 mL/min Standard Deviation 5.174	70.86 mL/min Standard Deviation 0	65.17 mL/min Standard Deviation 10.065
To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods. Iohexol GFR	119.25 mL/min Standard Deviation 9.898	57.52 mL/min Standard Deviation 15.816	31.76 mL/min Standard Deviation 8.340	—	110.52 mL/min Standard Deviation 12.675

SECONDARY outcome

Timeframe: Baseline through day 22

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.

Outcome measures

Measure	Cohort 1 n=8 Participants eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 Participants eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 Participants eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 n=1 Participants sCr: ≥2-fold increase or eGFR: \>50% decrease compared to baseline	Cohort 5 n=8 Participants eGFR renal function ≥60 mL/min for normal function
To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume. FAST Plasma Volume	3251.088 mL Standard Deviation 452.6180	2926.941 mL Standard Deviation 568.1260	2816.244 mL Standard Deviation 533.7910	6046.770 mL Standard Deviation 0	2415.950 mL Standard Deviation 569.1105
To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume. Nadler's Formula Plasma Volume	2859.671 mL Standard Deviation 313.2253	3103.431 mL Standard Deviation 443.1221	3150.045 mL Standard Deviation 393.3610	5297.820 mL Standard Deviation 0	2805.234 mL Standard Deviation 412.2505

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 5

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort 1 n=8 participants at risk eGFR renal function ≥60 mL/min for normal function	Cohort 2 n=8 participants at risk eGFR renal function 30-59 mL/min for stage 3, moderate CKD	Cohort 3 n=8 participants at risk eGFR renal function 15-29 mL/min for stage 4, severe CKD	Cohort 4 n=1 participants at risk a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI	Cohort 5 n=8 participants at risk eGFR renal function ≥60 mL/min for normal function
Cardiac disorders Sinus bradycardia	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Eye disorders Conjunctival Hyperaemia	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Eye disorders Conjunctival Oedema	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Eye disorders Conjunctivitis	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Eye disorders Miosis	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	100.0% 1/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Eye disorders Vision Blurred	25.0% 2/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Gastrointestinal disorders Abdominal Pain	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	100.0% 1/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Gastrointestinal disorders Nausea	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	25.0% 2/8 • Baseline through day 22.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	25.0% 2/8 • Baseline through day 22.
General disorders Oedema	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
General disorders Oedema Peripheral	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	25.0% 2/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
General disorders Pain	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Infections and infestations Tinea Versicolour	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Infections and infestations Urinary Tract Infection	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Investigations Aspartate Aminotransferase Increased	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Investigations Blood Creatinine Increased	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Investigations Blood Potassium Increased	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Investigations Cardiac Murmur	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Investigations Liver Palpable Subcostal	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	100.0% 1/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Nervous system disorders Migraine	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Psychiatric disorders Depression	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/8 • Baseline through day 22.	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.
Vascular disorders Haematoma	12.5% 1/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.	0.00% 0/1 • Baseline through day 22.	0.00% 0/8 • Baseline through day 22.

Additional Information

Dana Victor Rizk, M.D.

University of Alabama, Birmingham

Email: drizk@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60