Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity |
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) |
Baseline to Week 14 |
|
| Secondary |
Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period |
The 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 |
Baseline to Week 12 |
|
| Secondary |
Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH) |
The number and percentage of subjects requiring early discontinuation from study treatment due to IDH summarized by treatment group |
Baseline to Week 12 |
|
| Secondary |
Change From Baseline in Montreal Cognitive Assessment (MoCA) |
Change 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. |
Screening to Week 14 |
|
| Secondary |
Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score |
Mean 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. |
Baseline to Week 12 |
|
| Secondary |
Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36) |
Mean 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. |
Baseline to Week 12 |
|
| Secondary |
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) |
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. |
Baseline to Week 14 |
|
| Secondary |
Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI) |
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. |
Baseline to Week 12 |
|
| Secondary |
Change From Baseline in Fatigue Per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT) |
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. |
Baseline to Week 12 |
|
| Secondary |
Number of Participants Who Discontinued Due to Anemia. |
The number and percentage of subjects with any anemia leading to discontinuation from AKST1210/control will be summarized by treatment group and total. |
Baseline to Week 12 |
|
| Secondary |
Tolerability as Measured by the Percentage of Subjects Who Complete Each Treatment Period |
The 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 |
Baseline to Week 12 |
|
| Secondary |
Tolerability as Measured by the Number of Subjects Who Complete the Run-In Period. |
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. |
Week -2 (Day -14) to Week -1 (Day -1) |
|
| Secondary |
Tolerability as Measured by the Percentage of Subjects Who Complete the Run-in Period |
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. |
Week -2 (Day -14) to Week -1 (Day -1) |
|
| Secondary |
Tolerability as Measured by the Number of Subjects Who Completed All Visits. |
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 |
Baseline to Week 14 |
|
| Secondary |
Tolerability as Measured by the Percentage of Subjects Who Completed All Visits. |
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 |
Baseline to Week 14 |
|
