Trial Outcomes & Findings for Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis (NCT NCT04985383)
NCT ID: NCT04985383
Last Updated: 2023-09-29
Results Overview
A TEAE is defined as an AE that occurs on or after the date of the first column use. Primary and secondary endpoints were assessed at the beginning and end of each week of treatment for a particular column size and blood-flow rate combination (S-15 250 mL/min, S-15 up to 450 mL/min, S-25 250 mL/min, S-25 up to 450 mL/min, S-35 250 mL/min, S-35 up to 450 mL/min). The effect of blood-flow rate was assessed for a given column size as well as intra-subject and across-subject variability.
COMPLETED
NA
10 participants
Screening to Week 7
2023-09-29
Participant Flow
Participant milestones
| Measure |
AKST1210 Device
AKST1210 column will be connected in series for the duration of each hemodialysis session. Participants will progress through 6 weeks of study treatment according to the following device and flow rate combinations:
Week 1: S-15 at 250 mL/min Week 2: S-15 at up to 450 mL/min Week 3: S-25 at 250 mL/min Week 4: S-25 at up to 450 mL/min Week 5: S-35 at 250 mL/min Week 6: S-35 at up to 450 mL/min
AKST1210: Procedure: Hemodialysis
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Week 1 AKST1210 S-15 at 250 mL/Min
|
9
|
|
Overall Study
Week 2 AKST1210 S-15 at up to 450 mL/Min
|
9
|
|
Overall Study
Week 3 AKST1210 S-25 at 250 mL/Min
|
9
|
|
Overall Study
Week 4 AKST1210 S-25 at up to 450 mL/Min
|
9
|
|
Overall Study
Week 5 AKST1210 S-35 at 250 mL/Min
|
9
|
|
Overall Study
Week 6 AKST1210 S-35 at up to 450 mL/Min
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis
Baseline characteristics by cohort
| Measure |
AKST1210 Device
n=10 Participants
AKST1210 column will be connected in series for the duration of each hemodialysis session.
AKST1210: Procedure: Hemodialysis
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Women of Child Bearing Potential (WOCBP)
No
|
9 Participants
n=5 Participants
|
|
Women of Child Bearing Potential (WOCBP)
Yes
|
1 Participants
n=5 Participants
|
|
Baseline Body Mass Index (BMI)
|
30.5 kg/m^2
STANDARD_DEVIATION 4.07 • n=5 Participants
|
|
Number of Subjects with Baseline Historical IDH Rate
0
|
9 Participants
n=5 Participants
|
|
Number of Subjects with Baseline Historical IDH Rate
1
|
1 Participants
n=5 Participants
|
|
Number of Subjects with Baseline Historical IDH Rate
2
|
0 Participants
n=5 Participants
|
|
Number of Subjects with Baseline Historical IDH Rate
3
|
0 Participants
n=5 Participants
|
|
Number of Subjects with Baseline Historical IDH Rate
4
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening to Week 7Population: Safety population: all subjects who received at least 1 (or partial) HD treatment with the AKST1210. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
A TEAE is defined as an AE that occurs on or after the date of the first column use. Primary and secondary endpoints were assessed at the beginning and end of each week of treatment for a particular column size and blood-flow rate combination (S-15 250 mL/min, S-15 up to 450 mL/min, S-25 250 mL/min, S-25 up to 450 mL/min, S-35 250 mL/min, S-35 up to 450 mL/min). The effect of blood-flow rate was assessed for a given column size as well as intra-subject and across-subject variability.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Safety as Evaluated by Rate and Severity of Treatment-emergent AEs (TEAEs)
Severity - Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Evaluated by Rate and Severity of Treatment-emergent AEs (TEAEs)
Severity - Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety as Evaluated by Rate and Severity of Treatment-emergent AEs (TEAEs)
Severity - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Safety population: all subjects who received at least 1 (or partial) HD treatment with the AKST1210 column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
The number and percentage of subjects with Intradialytic Hypotensive (IDH) event(s) summarized by column size and blood-flow rate combination. Primary and secondary endpoints were assessed at the beginning and end of each week of treatment for a particular column size and blood-flow rate combination (S-15 250 mL/min, S-15 up to 450 mL/min, S-25 250 mL/min, S-25 up to 450 mL/min, S-35 250 mL/min, S-35 up to 450 mL/min). The effect of blood-flow rate was assessed for a given column size as well as intra-subject and across-subject variability.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Safety as Evaluated by the Number of Subjects With Intradialytic Hypotensive (IDH) Events
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Safety population: all subjects who received at least 1 (or partial) HD treatment with the AKST1210 column. Subjects with missing Hgb data ( S-24 at 250mL/min and S-25 at 450mL/min) are excluded from the number analyzed. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
Changes in post-HD total hemoglobin at baseline (i.e., the last non-missing value prior to the start of HD with the AKST1210 column) and each scheduled post-baseline timepoint summarized by each column size and blood-flow rate combination.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Safety as Evaluated by Changes in Total Hemoglobin (Hgb)
|
4.9 mg/dL
Standard Deviation 10.76
|
2.2 mg/dL
Standard Deviation 9.06
|
-4.3 mg/dL
Standard Deviation 11.53
|
-7.1 mg/dL
Standard Deviation 14.86
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Safety population: all subjects who received at least 1 (or partial) HD treatment with the AKST1210 column. Subjects with missing Hgb data ( S-24 at 250mL/min and S-25 at 450mL/min) are excluded from the number analyzed. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
Changes in post-HD free hemoglobin at baseline (i.e., the last non-missing value prior to the start of HD with the AKST1210 column) and each scheduled post-baseline timepoint summarized by each column size and blood-flow rate combination.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Safety as Evaluated by Changes in Free Hemoglobin (Hgb)
|
3.4 mg/dL
Standard Deviation 8.04
|
1.5 mg/dL
Standard Deviation 12.34
|
49.0 mg/dL
Standard Deviation 123.87
|
8.7 mg/dL
Standard Deviation 15.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min). The number analyzed within each row reflects the available data that was collected for subjects during each treatment period. Subjects with missing Kt/v data are excluded from the number analyzed.
Kt/V summarized at baseline and by each column size and flow-rate combination. Kt/V is calculated with Daugirdas' formula from the pre-dialysis to post-dialysis urea nitrogen ratio (R), the weight loss (UF), session length in hours (t), and anthropometric or modeled volume (V) using the equation: Kt/V = In (R - 0.008 x t) + (4 - 3.5 x R) x 0.55 UF/V.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=8 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=7 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=8 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=8 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Adequacy of Hemodialysis Measured With Kt/V
|
1.3 Kt/V
Standard Deviation 0.21
|
1.8 Kt/V
Standard Deviation 0.28
|
1.2 Kt/V
Standard Deviation 0.21
|
1.6 Kt/V
Standard Deviation 0.43
|
1.4 Kt/V
Standard Deviation 0.25
|
1.6 Kt/V
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min). The number analyzed within each row reflects the available data that was collected for subjects during each treatment period. Subjects with missing URR data are excluded from the number analyzed.
Weekly URR (%) measurements calculated as URR (%) = (1 - post-dialysis BUN / pre-dialysis BUN) \* 100 and summarized by each column size and flow-rate combination. Pre-dialysis BUN and Post-Dialysis BUN are hemodialysis values observed within the same dialysis session. URR is a measure of the proportionate reduction in blood urea nitrogen over the course of dialysis.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=8 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=8 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=7 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=8 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=6 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=7 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Adequacy of Hemodialysis Measured by Urea Reduction Ratio (URR)
|
66.2 URR percentage
Standard Deviation 3.95
|
77.1 URR percentage
Standard Deviation 3.95
|
55.0 URR percentage
Standard Deviation 25.00
|
74.1 URR percentage
Standard Deviation 11.75
|
68.2 URR percentage
Standard Deviation 3.13
|
75.0 URR percentage
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min).
Actual fluid removal is calculated as follows: Weight (kg) - Weight Post-Dialysis (kg) and subsequently converting weight to volume (1 kg = 1000 mL). Each week contains 3 visits, as indicated in the following parentheses: Week 1 - S-15 at 250 mL/min: Visit 5 (Visit #1), Visit 6 (Visit #2), Visit 7 (Visit #3) Week 2 - S-15 at up to 450 mL/min: Visit 8 (Visit #1), Visit 9 (Visit #2), Visit 10 (Visit #3) Week 3 - S-25 at 250 mL/min: Visit 11 (Visit #1), Visit 12 (Visit #2), Visit 13 (Visit #3) Week 4 - S-25 at up to 450 mL/min: Visit 14 (Visit #1), Visit 15 (Visit #2), Visit 16 (Visit #3) Week 5 - S-35 at 250 mL/min: Visit 17 (Visit #1), Visit 18 (Visit #2), Visit 19 (Visit #3) Week 6 - S-35 at up to 450 mL/min: Visit 20 (Visit #1), Visit 21 (Visit #2), Visit 22 (Visit #3)
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Total Fluid Balance for Each Column-Size Blood-Flow Rate Combination
Visit #3
|
2588.9 mL
Standard Deviation 814.62
|
2233.3 mL
Standard Deviation 1206.23
|
2822.2 mL
Standard Deviation 948.39
|
2288.9 mL
Standard Deviation 1076.39
|
2500.0 mL
Standard Deviation 873.21
|
2355.6 mL
Standard Deviation 935.56
|
|
Total Fluid Balance for Each Column-Size Blood-Flow Rate Combination
Visit #1
|
2144.4 mL
Standard Deviation 559.27
|
2288.9 mL
Standard Deviation 991.77
|
1933.3 mL
Standard Deviation 1065.36
|
2344.4 mL
Standard Deviation 1143.58
|
2100.0 mL
Standard Deviation 796.87
|
2566.7 mL
Standard Deviation 890.22
|
|
Total Fluid Balance for Each Column-Size Blood-Flow Rate Combination
Visit #2
|
1711.1 mL
Standard Deviation 1085.64
|
1955.6 mL
Standard Deviation 970.97
|
1888.9 mL
Standard Deviation 470.22
|
1855.6 mL
Standard Deviation 907.07
|
2222.2 mL
Standard Deviation 924.36
|
2100.0 mL
Standard Deviation 680.07
|
SECONDARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min).
Number of subjects who were able to achieve the dry weight goal during the allotted HD duration for each visit and column size and blood-flow rate combination. Each week contains 3 visits, as indicated in the following parentheses: Week 1 - S-15 at 250 mL/min: Visit 5 (Visit #1), Visit 6 (Visit #2), Visit 7 (Visit #3) Week 2 - S-15 at up to 450 mL/min: Visit 8 (Visit #1), Visit 9 (Visit #2), Visit 10 (Visit #3) Week 3 - S-25 at 250 mL/min: Visit 11 (Visit #1), Visit 12 (Visit #2), Visit 13 (Visit #3) Week 4 - S-25 at up to 450 mL/min: Visit 14 (Visit #1), Visit 15 (Visit #2), Visit 16 (Visit #3) Week 5 - S-35 at 250 mL/min: Visit 17 (Visit #1), Visit 18 (Visit #2), Visit 19 (Visit #3) Week 6 - S-35 at up to 450 mL/min: Visit 20 (Visit #1), Visit 21 (Visit #2), Visit 22 (Visit #3)
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Dry Weight Goal
Visit #1
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Who Achieved the Dry Weight Goal
Visit #2
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Who Achieved the Dry Weight Goal
Visit #3
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 1 (V7) - S-15 at 250 mL/min, Week 2 (V10) - S-15 at up to 450 mL/min, Week 3 (V13) - S-25 at 250 mL/min, Week 4 (V16) - S-25 at up to 450 mL/min, Week 5 (V19) - S-35 at 250 mL/min, Week 6 (V22) - S-35 at up to 450 mL/minPopulation: The b2M Population consists of a subset of the evaluable population that excludes any subjects with Major Protocol Deviations pertaining to blood flow rate as well as any subjects who have documented blood flow rate deviations exceeding +/- 20 mL/min of the protocol-specified blood flow rate at Visits 4, 7, 10, 13, 16, 19 and/or 22.
Least-squares mean arterial ratios (end-HD/pre-HD) and associated 95% confidence intervals (CIs) were determined from a Mixed Model Repeated Measure (MMRM) for the end-HD/pre-HD arterial ratio in the logarithmic scale, with visits (V7, V10, V13, V16, V19, and V22) as a fixed effect, a covariate for baseline b2M protein levels, and a random intercept and covariate for investigational site (or dialyzer type). Note: Visits correspond to blood-flow rate and column combinations.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=7 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=7 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=7 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=7 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=7 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=7 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Plasma Beta-2 Microglobulin (b2M) Concentrations (Before and After HD) and Contribution of the AKST1210 Column to b2M Removal at Each Column Size and Blood-flow Rate
|
-0.9 log ratio (mg/L)
Interval -1.2 to -0.6
|
-1.0 log ratio (mg/L)
Interval -1.3 to -0.7
|
-0.8 log ratio (mg/L)
Interval -1.1 to -0.5
|
-1.1 log ratio (mg/L)
Interval -1.4 to -0.9
|
-0.9 log ratio (mg/L)
Interval -1.2 to -0.6
|
-1.3 log ratio (mg/L)
Interval -1.6 to -1.0
|
SECONDARY outcome
Timeframe: Week 1 - S-15 at 250 mL/min, Week 2 - S-15 at up to 450 mL/min, Week 3 - S-25 at 250 mL/min, Week 4 - S-25 at up to 450 mL/min, Week 5 - S-35 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Safety population: all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
Number of occurrences of visible thrombosis (clotting) in the AKST1210 column, dialyzer, and/or tubing by column size and blood-flow rate combination.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
n=9 Participants
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
n=9 Participants
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
n=9 Participants
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Number of Occurrences of Visible Thrombosis (Clotting) in the AKST1210 Column, Dialyzer, and/or Tubing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 - S-15 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min). All column size/blood-flow rate are included in this analysis population. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
Plasma levels of complement factors, including total CH50, SC5b-9, and C5a, are summarized by visit for combined column size and blood-flow rate combinations.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
CH50, Baseline Post-HD
|
67.4 g/L
Standard Deviation 12.14
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
CH50, Visit 7 Post-HD
|
63.6 g/L
Standard Deviation 13.89
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
CH50, Visit 22 Post-HD
|
61.5 g/L
Standard Deviation 13.43
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
SC5b-9, Baseline Post-HD
|
296.7 g/L
Standard Deviation 101.59
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
SC5b-9, Visit 7 Post-HD
|
624.2 g/L
Standard Deviation 157.34
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
SC5b-9, Visit 22 Post-HD
|
896.7 g/L
Standard Deviation 209.87
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
C5a, Baseline Post-HD
|
9.5 g/L
Standard Deviation 3.97
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
C5a, Visit 7 Post-HD
|
9.5 g/L
Standard Deviation 4.08
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a
C5a, Visit 22 Post-HD
|
8.9 g/L
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1 - S-15 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min). All column size/blood-flow rate are included in this analysis population.
Plasma levels of other proteins, including insulin and ACTH, at each schedule timepoint summarized by visit for combined column size and blood-flow rate combination.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
Insulin, Baseline Post HD
|
87.7 pmol/L
Standard Deviation 76.23
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
Insulin, Visit 7 Post HD
|
64.4 pmol/L
Standard Deviation 43.80
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
Insulin, Visit 22 Post HD
|
35.2 pmol/L
Standard Deviation 13.43
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
ACTH, Baseline Post HD
|
11.1 pmol/L
Standard Deviation 7.79
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
ACTH, Visit 7 Post HD
|
8.9 pmol/L
Standard Deviation 6.19
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH)
ACTH, Visit 22 Post HD
|
8.7 pmol/L
Standard Deviation 10.37
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1 - S-15 at 250 mL/min, Week 6 - S-35 at up to 450 mL/minPopulation: Evaluable population: all subjects who completed blood-flow rates up to 450 mL/min for at least 1 column size (e.g., S-15 at 250 and up to 450 mL/min). All column size/blood-flow rate are included in this analysis population.
Plasma levels of other proteins, including IGFBP1, at each schedule timepoint summarized by visit for combined column size and blood-flow rate combination.
Outcome measures
| Measure |
S-15 at 250 mL/Min
n=10 Participants
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
S-15 at 450 mL/Min
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
S-25 at 250 mL/Min
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
S-25 at 450 mL/Min
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
S-35 at 250 mL/Min
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
S-35 at 450 mL/Min
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|
|
Plasma Levels of Other Proteins, Including Insulin-Like Growth Factor Binding Prot1 (IGFBP1)
IGFBP1, Baseline Post HD
|
86.5 ug/L
Standard Deviation 66.62
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin-Like Growth Factor Binding Prot1 (IGFBP1)
IGFBP1, Visit 7 Post HD
|
92.6 ug/L
Standard Deviation 66.19
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Levels of Other Proteins, Including Insulin-Like Growth Factor Binding Prot1 (IGFBP1)
IGFBP1, Visit 22 Post HD
|
114.7 ug/L
Standard Deviation 91.38
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Screening/Run-in
AKST1210 S-15 at 250 mL/Min
AKST1210 S-15 at up to 450 mL/Min
AKST1210 S-25 at 250 mL/Min
AKST1210 S-25 at up to 450 mL/Min
AKST1210 S-35 at 250 mL/Min
AKST1210 S-35 at up to 450 mL/Min
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Screening/Run-in
n=10 participants at risk
No AKST1210 column will be used during the Screening/Run-in period.
Procedure: Hemodialysis
|
AKST1210 S-15 at 250 mL/Min
n=10 participants at risk
AKST1210 column size 150mL and blood-flow rate at 250mL/min
|
AKST1210 S-15 at up to 450 mL/Min
n=9 participants at risk
AKST1210 column size 150mL and blood-flow rate at 450mL/min
|
AKST1210 S-25 at 250 mL/Min
n=9 participants at risk
AKST1210 column size 250mL and blood-flow rate at 250mL/min
|
AKST1210 S-25 at up to 450 mL/Min
n=9 participants at risk
AKST1210 column size 250mL and blood-flow rate at 450mL/min
|
AKST1210 S-35 at 250 mL/Min
n=9 participants at risk
AKST1210 column size 350mL and blood-flow rate at 250mL/min
|
AKST1210 S-35 at up to 450 mL/Min
n=9 participants at risk
AKST1210 column size 350mL and blood-flow rate at 450mL/min
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
11.1%
1/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
11.1%
1/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
|
Vascular disorders
Dialysis hypotension
|
10.0%
1/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
20.0%
2/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
10.0%
1/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/10 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
0.00%
0/9 • Approximately 12 weeks (up to 4 weeks for screening and 8 weeks on study, inclusive of the 1-week run-in period)
Safety population includes all subjects who received at least 1 (or partial) HD treatment with the LIXELLE column. NOTE: 10 participants entered the period "AKST1210 S-15 at 250 mL/min," however 9 participants completed all visits in this period and progressed to the following week "AKST1210 S-15 at up to 450 mL/min."
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement contains language that restricts the PI from discussing or publishing Sponsor confidential and/or proprietary information. The embargo period may be extended by mutual agreement of the Sponsor and PI.
- Publication restrictions are in place
Restriction type: OTHER