Trial Outcomes & Findings for Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients (NCT NCT03257410)
NCT ID: NCT03257410
Last Updated: 2025-07-14
Results Overview
FLC=free light chains
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
Week 24
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
Theranova 400
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Theranova 400
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Renal transplantation
|
2
|
0
|
|
Overall Study
Switch to peritoneal dialysis
|
1
|
0
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Change to another dialysis center
|
2
|
2
|
|
Overall Study
Missing 3 consecutive study treatments
|
5
|
6
|
|
Overall Study
Miscellaneous
|
2
|
2
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
Baseline characteristics by cohort
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set. Number of subjects (n) with evaluable data is shown.
FLC=free light chains
Outcome measures
| Measure |
Theranova 400
n=82 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=79 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of Lambda Immunoglobulin FLC at Week 24
|
32.156 percentage ratio
Standard Deviation 12.602
|
17.514 percentage ratio
Standard Deviation 12.7235
|
PRIMARY outcome
Timeframe: Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=84 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=83 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Pre-dialysis Serum Level of Albumin at Week 24
|
4.030 g/dL
Standard Deviation 0.2843
|
4.018 g/dL
Standard Deviation 0.3935
|
SECONDARY outcome
Timeframe: Week 4 and Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
FLC=free light chains
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
Week 4
|
39.3 percentage ratio
Standard Deviation 14.487
|
19.88 percentage ratio
Standard Deviation 11.394
|
|
Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
Week 24
|
33.29 percentage ratio
Standard Deviation 10.96
|
17.19 percentage ratio
Standard Deviation 12.863
|
SECONDARY outcome
Timeframe: Week 4 and 24Population: FAS. Number of subjects (n) with evaluable data is shown.
CFD=complement factor D
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of Complement Factor D
Week 4
|
36.78 percentage ratio
Standard Deviation 26.499
|
11.71 percentage ratio
Standard Deviation 27.71
|
|
Reduction Ratio of Complement Factor D
Week 24
|
38.09 percentage ratio
Standard Deviation 11.233
|
14.55 percentage ratio
Standard Deviation 11.298
|
SECONDARY outcome
Timeframe: Week 4 and 24Population: FAS. Number of subjects (n) with evaluable data is shown.
κ FLC = Kappa Free light chains
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of κ FLC
Week 4
|
65.63 percentage ratio
Standard Deviation 18.566
|
49.74 percentage ratio
Standard Deviation 15.111
|
|
Reduction Ratio of κ FLC
Week 24
|
59.27 percentage ratio
Standard Deviation 13.068
|
43.91 percentage ratio
Standard Deviation 14.882
|
SECONDARY outcome
Timeframe: Week 4 and 24Population: FAS. Number of subjects (n) with evaluable data is shown.
IL-6=interleukin 6
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of Interleukin 6
Week 4
|
-4.62 percentage ratio
Standard Deviation 49.378
|
-22.21 percentage ratio
Standard Deviation 69.618
|
|
Reduction Ratio of Interleukin 6
Week 24
|
-0.85 percentage ratio
Standard Deviation 46.214
|
-14.83 percentage ratio
Standard Deviation 43.574
|
SECONDARY outcome
Timeframe: Week 4 and 24Population: FAS. Number of subjects (n) with evaluable data is shown.
TNFα=tumor necrosis factor alpha
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of Tumor Necrosis Factor Alpha
Week 4
|
47.29 percentage ratio
Standard Deviation 9.966
|
37.9 percentage ratio
Standard Deviation 8.892
|
|
Reduction Ratio of Tumor Necrosis Factor Alpha
Week 24
|
44.48 percentage ratio
Standard Deviation 10.215
|
34.52 percentage ratio
Standard Deviation 10.673
|
SECONDARY outcome
Timeframe: Week 4 and 24Population: FAS. Number of subjects (n) with evaluable data is shown.
β2=beta 2
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Reduction Ratio of β2-microglobulin
Week 4
|
75.67 percentage ratio
Standard Deviation 8.2
|
64.86 percentage ratio
Standard Deviation 8.903
|
|
Reduction Ratio of β2-microglobulin
Week 24
|
73.64 percentage ratio
Standard Deviation 10.426
|
65.41 percentage ratio
Standard Deviation 9.428
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis β2-microglobulin at Week 24
|
-3.95 mg/L
Standard Deviation 5.614
|
-1.16 mg/L
Standard Deviation 6.128
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Kt/Vurea
Week 4
|
1.58 Kt/Vurea
Standard Deviation 0.266
|
1.58 Kt/Vurea
Standard Deviation 0.427
|
|
Kt/Vurea
Week 8
|
1.62 Kt/Vurea
Standard Deviation 0.288
|
1.51 Kt/Vurea
Standard Deviation 0.316
|
|
Kt/Vurea
Week 12
|
1.58 Kt/Vurea
Standard Deviation 0.294
|
1.55 Kt/Vurea
Standard Deviation 0.328
|
|
Kt/Vurea
Week 16
|
1.56 Kt/Vurea
Standard Deviation 0.268
|
1.59 Kt/Vurea
Standard Deviation 0.48
|
|
Kt/Vurea
Week 20
|
1.57 Kt/Vurea
Standard Deviation 0.297
|
1.55 Kt/Vurea
Standard Deviation 0.371
|
|
Kt/Vurea
Week 24
|
1.51 Kt/Vurea
Standard Deviation 0.31
|
1.54 Kt/Vurea
Standard Deviation 0.467
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 16
|
-0.13 g/dL
Standard Deviation 0.335
|
-0.03 g/dL
Standard Deviation 0.315
|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 20
|
-0.08 g/dL
Standard Deviation 0.279
|
0.02 g/dL
Standard Deviation 0.258
|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 24
|
0.01 g/dL
Standard Deviation 0.250
|
0.04 g/dL
Standard Deviation 0.256
|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 4
|
-0.08 g/dL
Standard Deviation 0.244
|
0 g/dL
Standard Deviation 0.203
|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 8
|
-0.11 g/dL
Standard Deviation 0.254
|
0.00 g/dL
Standard Deviation 0.216
|
|
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Week 12
|
-0.12 g/dL
Standard Deviation 0.289
|
-0.04 g/dL
Standard Deviation 0.229
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis Factor VII by Visit
Week 12
|
3.59 percentage activity
Standard Deviation 24.057
|
7.79 percentage activity
Standard Deviation 27.798
|
|
Change From Baseline in Pre-dialysis Factor VII by Visit
Week 24
|
0.38 percentage activity
Standard Deviation 34.572
|
9.19 percentage activity
Standard Deviation 48.575
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis Protein C by Visit
Week 12
|
1.12 percentage activity
Standard Deviation 15.711
|
1.76 percentage activity
Standard Deviation 16.378
|
|
Change From Baseline in Pre-dialysis Protein C by Visit
Week 24
|
0.14 percentage activity
Standard Deviation 19.376
|
-1.78 percentage activity
Standard Deviation 18.781
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis Vitamin A by Visit
Week 4
|
-0.29 μmol/L
Standard Deviation 0.983
|
-0.04 μmol/L
Standard Deviation 0.939
|
|
Change From Baseline in Pre-dialysis Vitamin A by Visit
Week 24
|
-0.33 μmol/L
Standard Deviation 0.832
|
-0.15 μmol/L
Standard Deviation 1.096
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24Population: FAS. Number of subjects (n) with evaluable data is shown.
nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
nPNA (nPCR)
Week 4
|
0.983 g/kg/d
Standard Deviation 0.2473
|
1.056 g/kg/d
Standard Deviation 0.3088
|
|
nPNA (nPCR)
Week 8
|
1.013 g/kg/d
Standard Deviation 0.2380
|
1.023 g/kg/d
Standard Deviation 0.2936
|
|
nPNA (nPCR)
Week 12
|
0.971 g/kg/d
Standard Deviation 0.2573
|
1.030 g/kg/d
Standard Deviation 0.2664
|
|
nPNA (nPCR)
Week 16
|
1.022 g/kg/d
Standard Deviation 0.2869
|
0.971 g/kg/d
Standard Deviation 0.2881
|
|
nPNA (nPCR)
Week 20
|
0.988 g/kg/d
Standard Deviation 0.2666
|
1.024 g/kg/d
Standard Deviation 0.3366
|
|
nPNA (nPCR)
Week 24
|
0.947 g/kg/d
Standard Deviation 0.2450
|
1.012 g/kg/d
Standard Deviation 0.2891
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Factor II (Prothrombin)
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-dialysis Factor II by Visit
Week 24
|
3.85 percent activity
Standard Deviation 11.678
|
5.78 percent activity
Standard Deviation 15.394
|
|
Change From Baseline in Pre-dialysis Factor II by Visit
Week 12
|
3.45 percent activity
Standard Deviation 11.507
|
3.19 percent activity
Standard Deviation 13.284
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)
|
-0.20 mmol/L
Standard Deviation 3.192
|
0.00 mmol/L
Standard Deviation 3.671
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)
|
0.08 mmol/L
Standard Deviation 0.727
|
-0.23 mmol/L
Standard Deviation 0.665
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)
|
-0.06 mmol/L
Standard Deviation 0.154
|
-0.02 mmol/L
Standard Deviation 0.151
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)
|
-0.03 mmol/L
Standard Deviation 0.438
|
-0.19 mmol/L
Standard Deviation 0.500
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)
|
0.09 mmol/L
Standard Deviation 3.488
|
0.43 mmol/L
Standard Deviation 4.108
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)
|
1.31 mmol/L
Standard Deviation 3.053
|
1.37 mmol/L
Standard Deviation 3.080
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)
|
-0.20 mmol/L
Standard Deviation 2.197
|
0.47 mmol/L
Standard Deviation 2.858
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)
|
-0.04 Sec
Standard Deviation 4.016
|
-0.49 Sec
Standard Deviation 6.305
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)
|
-0.01 ratio
Standard Deviation 0.341
|
-0.05 ratio
Standard Deviation 0.527
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=69 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)
|
-0.82 Sec
Standard Deviation 16.682
|
-0.96 Sec
Standard Deviation 15.424
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=60 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=54 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)
|
0.03 L/L
Standard Deviation 0.055
|
0.01 L/L
Standard Deviation 0.042
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)
|
2.74 g/L
Standard Deviation 15.569
|
-0.11 g/L
Standard Deviation 11.221
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)
|
-0.12 pg
Standard Deviation 1.079
|
-0.35 pg
Standard Deviation 1.153
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=71 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)
|
-18.54 g/L
Standard Deviation 16.053
|
-15.12 g/L
Standard Deviation 21.075
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=60 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=54 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)
|
4.88 fL
Standard Deviation 5.371
|
1.93 fL
Standard Deviation 4.778
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Platelets at End of Study (up to Week 24)
|
-8.65 10^9 cells/L
Standard Deviation 41.711
|
7.99 10^9 cells/L
Standard Deviation 49.215
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Erythrocytes at End of Study (up to Week 24)
|
0.10 10^12 cells/L
Standard Deviation 0.482
|
0.04 10^12 cells/L
Standard Deviation 0.365
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Leukocytes at End of Study (up to Week 24)
|
-0.22 10^9 cells/L
Standard Deviation 1.640
|
0.49 10^9 cells/L
Standard Deviation 2.464
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Basophils (%) at End of Study (up to Week 24)
|
0.05 % of total white blood count (WBC)
Standard Deviation 0.369
|
-0.02 % of total white blood count (WBC)
Standard Deviation 0.408
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)
|
0.17 % of total WBC
Standard Deviation 3.259
|
-0.29 % of total WBC
Standard Deviation 2.397
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)
|
0.14 % of total WBC
Standard Deviation 6.979
|
-0.69 % of total WBC
Standard Deviation 8.052
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Monocytes (%) at End of Study (up to Week 24)
|
-0.49 % of total WBC
Standard Deviation 2.261
|
-1.07 % of total WBC
Standard Deviation 3.479
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=76 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)
|
0.16 % of total WBC
Standard Deviation 8.744
|
1.98 % of total WBC
Standard Deviation 9.485
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=63 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
|
-1.82 mmol urea/L
Standard Deviation 5.299
|
-0.69 mmol urea/L
Standard Deviation 4.784
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=61 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
|
-0.53 mmol urea/L
Standard Deviation 2.360
|
-0.57 mmol urea/L
Standard Deviation 2.066
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=60 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=63 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)
|
0.33 no unit
Standard Deviation 9.298
|
0.68 no unit
Standard Deviation 8.963
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)
|
-17.45 μmol/L
Standard Deviation 160.343
|
-36.44 μmol/L
Standard Deviation 153.168
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=86 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Kt/Vurea by Visit
Week 4
|
1.58 no unit
Standard Deviation 0.266
|
1.58 no unit
Standard Deviation 0.427
|
|
Kt/Vurea by Visit
Week 8
|
1.62 no unit
Standard Deviation 0.288
|
1.51 no unit
Standard Deviation 0.316
|
|
Kt/Vurea by Visit
Week 12
|
1.58 no unit
Standard Deviation 0.294
|
1.55 no unit
Standard Deviation 0.328
|
|
Kt/Vurea by Visit
Week 16
|
1.56 no unit
Standard Deviation 0.268
|
1.59 no unit
Standard Deviation 0.480
|
|
Kt/Vurea by Visit
Week 20
|
1.57 no unit
Standard Deviation 0.297
|
1.55 no unit
Standard Deviation 0.371
|
|
Kt/Vurea by Visit
Week 24
|
1.51 no unit
Standard Deviation 0.310
|
1.54 no unit
Standard Deviation 0.467
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=58 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=58 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)
|
-0.35 μmol/L
Standard Deviation 0.826
|
-0.01 μmol/L
Standard Deviation 0.899
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)
|
-0.19 mmol/L
Standard Deviation 0.766
|
-0.24 mmol/L
Standard Deviation 0.705
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)
|
0.04 mmol/L
Standard Deviation 0.266
|
-0.03 mmol/L
Standard Deviation 0.276
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)
|
-0.07 mmol/L
Standard Deviation 0.663
|
-0.18 mmol/L
Standard Deviation 0.807
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)
|
-0.15 mmol/L
Standard Deviation 0.661
|
-0.02 mmol/L
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)
|
-1.97 U/L
Standard Deviation 37.783
|
2.19 U/L
Standard Deviation 32.725
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=70 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=70 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)
|
-2.17 U/L
Standard Deviation 8.168
|
-0.51 U/L
Standard Deviation 8.018
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=69 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=69 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)
|
-0.75 U/L
Standard Deviation 6.816
|
-0.01 U/L
Standard Deviation 5.870
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=3 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=7 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)
|
1.53 μmol/L
Standard Deviation 2.603
|
0.23 μmol/L
Standard Deviation 1.107
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=72 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)
|
-1.06 μmol/L
Standard Deviation 2.960
|
-0.66 μmol/L
Standard Deviation 2.040
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)
|
-0.66 U/L
Standard Deviation 22.587
|
-1.68 U/L
Standard Deviation 21.724
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Protein (g/L) at End of Study (up to Week 24)
|
-1.55 g/L
Standard Deviation 4.576
|
-0.95 g/L
Standard Deviation 4.223
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=73 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)
|
-2.07 g/L
Standard Deviation 3.635
|
-1.27 g/L
Standard Deviation 3.216
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=47 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=49 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)
|
-0.96 mg/L
Standard Deviation 4.168
|
-0.40 mg/L
Standard Deviation 4.600
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=68 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=67 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)
|
3.85 percentage activity
Standard Deviation 11.678
|
5.78 percentage activity
Standard Deviation 15.394
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=75 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=74 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)
|
0.01 g/dL
Standard Deviation 0.250
|
0.04 g/dL
Standard Deviation 0.256
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=71 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=67 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)
|
0.14 percentage activity
Standard Deviation 19.376
|
-1.78 percentage activity
Standard Deviation 18.781
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)
|
-0.47 pg/mL
Standard Deviation 1.999
|
0.08 pg/mL
Standard Deviation 1.645
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=67 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=67 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)
|
0.38 percentage activity
Standard Deviation 34.572
|
9.19 percentage activity
Standard Deviation 48.575
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)
|
-19.40 mg/L
Standard Deviation 31.635
|
1.75 mg/L
Standard Deviation 29.946
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)
|
0.20 pg/mL
Standard Deviation 5.449
|
1.64 pg/mL
Standard Deviation 6.473
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=62 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)
|
0.13 mcg/mL
Standard Deviation 4.742
|
1.89 mcg/mL
Standard Deviation 4.838
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=65 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)
|
-84.81 mg/L
Standard Deviation 97.359
|
-43.01 mg/L
Standard Deviation 75.677
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Number of subjects (n) with evaluable data is shown.
Outcome measures
| Measure |
Theranova 400
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=64 Participants
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)
|
-3.95 mg/L
Standard Deviation 5.614
|
-1.16 mg/L
Standard Deviation 6.128
|
Adverse Events
Theranova 400
Serious events: 15 serious events
Other events: 14 other events
Deaths: 3 deaths
Elisio-17H
Serious events: 23 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Theranova 400
n=86 participants at risk
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=85 participants at risk
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
2.4%
2/85 • Number of events 2 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
CARDIAC ARREST
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
General disorders
CHEST PAIN
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
2.4%
2/85 • Number of events 2 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
General disorders
PAIN
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
General disorders
PYREXIA
|
2.3%
2/86 • Number of events 2 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
CELLULITIS
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
GRAFT INFECTION
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
PNEUMONIA
|
2.3%
2/86 • Number of events 2 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
SEPSIS
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA THROMBOSIS
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT COMPLICATION
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Metabolism and nutrition disorders
CALCIPHYLAXIS
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
3.5%
3/85 • Number of events 3 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL SQUAMOUS CELL CARCINOMA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Nervous system disorders
SEIZURE
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
2.4%
2/85 • Number of events 2 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Vascular disorders
AORTIC STENOSIS
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/86 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
1.2%
1/86 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
0.00%
0/85 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
Other adverse events
| Measure |
Theranova 400
n=86 participants at risk
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
Elisio-17H
n=85 participants at risk
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
7.0%
6/86 • Number of events 6 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
1.2%
1/85 • Number of events 1 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.0%
6/86 • Number of events 6 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
3.5%
3/85 • Number of events 3 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
3.5%
3/86 • Number of events 3 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
8.2%
7/85 • Number of events 17 • AEs/SAEs were collected after the informed consent was signed and throughout the study (week 24), until the end of study visit (week 25-26).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
- Publication restrictions are in place
Restriction type: OTHER