Trial Outcomes & Findings for A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment (NCT NCT04527328)
NCT ID: NCT04527328
Last Updated: 2022-12-12
Results Overview
Number of participants with Treatment-Emergent Adverse Events (TEAE) assessed by Intensity (mild, moderate, or severe) coded by the Medical Dictionary for Regulatory Activities (MedDRA)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline to Week 14
Results posted on
2022-12-12
Participant Flow
Participant milestones
| Measure |
AKST1210
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
AKST1210 S-15 or Control
|
5
|
5
|
|
Overall Study
AKST1210 S-25 or Control
|
5
|
5
|
|
Overall Study
AKST1210 S-35 or Control
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
Baseline characteristics by cohort
| Measure |
AKST1210 Device
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 14Number of participants with Treatment-Emergent Adverse Events (TEAE) assessed by Intensity (mild, moderate, or severe) coded by the Medical Dictionary for Regulatory Activities (MedDRA)
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
Mild TEAE
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
Moderate TEAE
|
2 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
Severe TEAE
|
2 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12The number of subjects will be summarized by AKST1210 column size (small, S-15; medium, S-25; and large, S-35) and control for subjects who completed all visits in the treatment period
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
n=4 Participants
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
n=5 Participants
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period
|
5 participants
|
5 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12The number and percentage of subjects requiring early discontinuation from study treatment due to IDH summarized by treatment group
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH)
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Week 14Change from baseline to EOS in the total Montreal Cognitive Assessment (MoCA) score, which assesses executive functions, naming, attention and concentration, language, abstraction, delayed recall, and orientation. The MoCA has a total score from 0 to 30 whereby all sub sections are summed. The scoring breakdown for all sub sections includes the following: Visuospatial and executive functioning: 0-5 points, naming: 0-3 points, attention: 0-6 points, language: 0-3 points, abstraction: 0-2 points, delayed recall: 0- 5 points, orientation: 0-6 points. 1 point is added to the test-taker's score if they have 12 years or less of formal education. Higher scores in all sub categories and total score indicate better cognition. The Mean change from baseline is the post-treatment value minus baseline value.
Outcome measures
| Measure |
AKST1210
n=2 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Attention
|
-1.0 score on a scale
Standard Deviation 0.00
|
0.2 score on a scale
Standard Deviation 0.45
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Language
|
0.0 score on a scale
Standard Deviation 0.00
|
0.2 score on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Total Score
|
1.0 score on a scale
Standard Deviation 1.41
|
0.6 score on a scale
Standard Deviation 1.14
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Visuospatial / Executive
|
0.5 score on a scale
Standard Deviation 0.71
|
-0.2 score on a scale
Standard Deviation 1.30
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Naming
|
0.5 score on a scale
Standard Deviation 0.71
|
0.0 score on a scale
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Abstraction
|
0.5 score on a scale
Standard Deviation 0.71
|
0.0 score on a scale
Standard Deviation 1.00
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Delayed Recall
|
2.0 score on a scale
Standard Deviation 0.00
|
0.4 score on a scale
Standard Deviation 1.52
|
—
|
—
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Orientation
|
0.0 score on a scale
Standard Deviation 0.00
|
-0.2 score on a scale
Standard Deviation 0.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Mean change from baseline to End of Treatment in CogState test battery composite scores. The CogState test battery is a simple, brief computerized battery designed to assess cognitive function in several areas including verbal learning, psychomotor function, visual attention, working memory, executive function, and verbal delayed recall. Higher scores indicate better outcomes for all composite scores. All composite scores have a range of -16 to 10. Z-Scores between ≥ 1 and \< 1.5 standard deviations (SD) below age-matched normative data are considered minor cognitive impairment. Z-Scores between ≥ 1.5 and \< 2 SD below age-matched normative data are considered mild cognitive impairment. Z-Scores ≥ 2 SD below age matched normative data are considered major cognitive impairment consistent with dementia.
Outcome measures
| Measure |
AKST1210
n=4 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Global Composite Score
|
-0.1 Z-score
Standard Deviation 2.07
|
0.4 Z-score
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Episodic Memory Domain Composite Score
|
-0.2 Z-score
Standard Deviation 1.30
|
0.5 Z-score
Standard Deviation 0.37
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Attention Domain Composite Score
|
0.0 Z-score
Standard Deviation 3.86
|
0.6 Z-score
Standard Deviation 2.12
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Executive Function Domain Composite Score
|
0.0 Z-score
Standard Deviation 1.70
|
0.1 Z-score
Standard Deviation 0.58
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Psychomotor Function Composite Score
|
0.6 Z-score
Standard Deviation 3.80
|
0.7 Z-score
Standard Deviation 2.53
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Working Memory Composite Score
|
-0.3 Z-score
Standard Deviation 2.74
|
0.6 Z-score
Standard Deviation 1.82
|
—
|
—
|
|
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
Verbal Learning Composite Score
|
-0.1 Z-score
Standard Deviation 1.71
|
0.3 Z-score
Standard Deviation 0.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Mean change from baseline in quality of life per the Short-Form Health Survey (SF-36), which evaluates quality of life measures. All scores range from 0 to 100 with higher scores indicating less disability. An increase or decrease in the mental health summary score or physical health summary score from baseline indicates a more favorable health status or a more unfavorable health status, respectfully, in the subject's quality of life related to mental or physical health.
Outcome measures
| Measure |
AKST1210
n=4 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36)
Physical Health Score
|
-9.6 score on a scale
Standard Deviation 12.35
|
-3.4 score on a scale
Standard Deviation 9.66
|
—
|
—
|
|
Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36)
Mental Health Score
|
0.7 score on a scale
Standard Deviation 6.59
|
4.1 score on a scale
Standard Deviation 9.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: Number analyzed for each row title reflects available data. Subjects with missing data at the End of Study visit are excluded.
Change from baseline to EOS in the Patient Health Questionnaire-9 (PHQ-9), which evaluates the severity of depression. Symptoms are rated from 0 (not at all) to 3 (nearly every day) and scores are summated for each subject across the 9 items. The total score range is 0-27. An increase or decrease in the PHQ-9 total score from baseline indicates greater severity or less severity, respectfully, in the subject's state of depression.
Outcome measures
| Measure |
AKST1210
n=4 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9)
|
3.5 score on a scale
Standard Deviation 5.20
|
-1.2 score on a scale
Standard Deviation 1.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Number analyzed for each row title reflects available data. Subjects with missing data at the End of Treatment visit are excluded.
Change from baseline in sleep quality as measured by the Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI), which measures the quality and patterns of sleep in older adults. It differentiates "poor" from "good" sleep by measuring 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The subject self-rates each of these 7 areas of sleep. The score for each domain ranges from 0 to 3, whereby higher scores for each reflect the negative (worse) extreme on the Likert Scale. The sum of all 7 domains is used to compute the total score (0 to 21). A global sum of "5" or greater indicates a "poor" sleeper. An increase or decrease in the PSQI total score from baseline indicates worsening or improvement, respectfully, in the subject's overall sleep quality.
Outcome measures
| Measure |
AKST1210
n=4 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Total Score
|
0.0 score on a scale
Standard Deviation 4.58
|
0.8 score on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Sleep Quality
|
0.3 score on a scale
Standard Deviation 0.58
|
0.2 score on a scale
Standard Deviation 0.45
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Sleep Latency
|
-0.3 score on a scale
Standard Deviation 1.53
|
0.2 score on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Sleep Duration
|
-0.3 score on a scale
Standard Deviation 0.50
|
0.0 score on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Habitual Sleep Efficiency
|
0.0 score on a scale
Standard Deviation 1.63
|
0.6 score on a scale
Standard Deviation 1.34
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Sleep Disturbances
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Use of Sleep Medication
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
Daytime Dysfunction over the Last Month
|
0.3 score on a scale
Standard Deviation 0.58
|
0.5 score on a scale
Standard Deviation 0.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Number analyzed for each row title reflects available data. Subjects with missing data at the End of Treatment visit are excluded.
Change from baseline to End of Treatment in fatigue as measured by the Functional Assessments of Chronic Illness Therapy (FACIT), which measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue for each question is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is 0 to 52. To get this total, each question answered is scored individually, summed, multiplied by 13, and lastly divided by the number of questions answered. The higher the total score, the better the quality of life.
Outcome measures
| Measure |
AKST1210
n=4 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Change From Baseline in Fatigue Per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT)
|
-0.5 score on a scale
Standard Deviation 10.12
|
0.2 score on a scale
Standard Deviation 5.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12The number and percentage of subjects with any anemia leading to discontinuation from AKST1210/control will be summarized by treatment group and total.
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Due to Anemia.
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12The percentage of subjects will be summarized by AKST1210 column size (small, S-15; medium, S-25; and large, S-35) and control for subjects who completed all visits in the treatment period
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
n=4 Participants
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
n=5 Participants
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Percentage of Subjects Who Complete Each Treatment Period
|
100.00 percentage of participants
|
100.00 percentage of participants
|
75.00 percentage of participants
|
100.00 percentage of participants
|
SECONDARY outcome
Timeframe: Week -2 (Day -14) to Week -1 (Day -1)The number of subjects who completed the run-in period prior to randomization and initiation of study treatment. Subjects who met all eligibility criteria assessed during screening were monitored during a two-week run-in period for ongoing assessment of eligibility, safety, and baseline assessments prior to randomization and initiation of study treatment.
Outcome measures
| Measure |
AKST1210
n=11 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Number of Subjects Who Complete the Run-In Period.
|
10 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week -2 (Day -14) to Week -1 (Day -1)The percentage of subjects who completed the run-in period prior to randomization and initiation of study treatment. Subjects who met all eligibility criteria assessed during screening were monitored during a two-week run-in period for ongoing assessment of eligibility, safety, and baseline assessments prior to randomization and initiation of study treatment.
Outcome measures
| Measure |
AKST1210
n=11 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Percentage of Subjects Who Complete the Run-in Period
|
90.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: One subject completed all visits in the S-25 treatment period but discontinued prior entering the S-35 treatment period. Another subject completed all visits in the S-35 treatment period but discontinued prior completing the End of Study Follow-up visit
The number of subjects will be summarized by column size (small, S-15; medium, S-25; and large, S-35) and control for subjects who completed all visits
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
n=4 Participants
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
n=5 Participants
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Number of Subjects Who Completed All Visits.
|
5 participants
|
5 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: Of the 4 subjects entering into Treatment Period 3 (S-35), one subject did not complete the End of Study follow-up visit
The percentage of subjects will be summarized by column size (small, S-15; medium, S-25; and large, S-35) and control for subjects who completed all visits
Outcome measures
| Measure |
AKST1210
n=5 Participants
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210 column
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 Participants
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
AKST1210 (S-35)
n=4 Participants
Extracorporeal device (S-35, 350 mL capacity) for use in conjunction with dialysis
|
Control Column
n=5 Participants
A sham control with no effect on the dialyzed blood will be used to mimic the appearance of an in-line AKST1210 device
|
|---|---|---|---|---|
|
Tolerability as Measured by the Percentage of Subjects Who Completed All Visits.
|
100.00 percentage of participants
|
100.00 percentage of participants
|
75.00 percentage of participants
|
100.00 percentage of participants
|
Adverse Events
AKST1210
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Sham Control (No Intervention)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AKST1210
n=5 participants at risk
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 participants at risk
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
Other adverse events
| Measure |
AKST1210
n=5 participants at risk
The AKST1210 column will be connected to the dialysis circuit during each dialysis session.
AKST1210: AKST1210
Hemodialysis: Hemodialysis
|
Sham Control (No Intervention)
n=5 participants at risk
A covered surrogate object of similar size and shape as the investigational device
Sham Control (No Intervention): A covered surrogate object of similar size and shape as the investigational device
Hemodialysis: Hemodialysis
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Vascular disorders
Dialysis hypotension
|
40.0%
2/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
0.00%
0/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
20.0%
1/5 • Approximately 16-20 weeks (up to 4 weeks for screening and 14 weeks on study, inclusive of the 2-week run-in period)
AEs were captured beginning at time of informed consent through EOS. AE status was followed by the investigator until resolved or considered stable, unless the subject was lost to follow up. Reporting of TEAEs and AEs followed the pre-specified analyses per the Statistical Analysis Plan (SAP) in which total safety events were summarized by randomization arm (AKST1210 combined or Control combined).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60