End Stage Renal Disease
Conditions
Brief summary
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events. Patients will undergo 3 dialysis sessions per week, for 24 weeks.
Interventions
DEVICETheranova 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.
DEVICEElisio-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.
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg. * Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing. * Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months. * Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2. * Currently being dialyzed at an in-center setting, on a schedule of 3 times per week. * Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period. * Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter); stable access will be confirmed by observed Kt/V \>= 1.2 for past 2 measurements, and/or achievement of within 15% the prescribed blood flow rate over 3 treatments prior to study entry.
Exclusion criteria
* Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman \<55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study. * Have chronic liver disease. * Have a known paraprotein-associated disease. * Have known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia, and active peptic ulcers). * Have had a major bleeding episode (i.e. soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to randomization. * Have had a blood (red blood cell) transfusion ≤ 12 weeks prior to randomization. * Have had an acute infection ≤ 4 weeks prior to randomization. * Have active cancer, except for basal cell or squamous cell skin cancer. * Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1.b * Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering \[asymptomatic\] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia). * Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition). * Have a positive serology test for human immunodeficiency virus or hepatitis infection. * Have a significant psychiatric disorder or mental disability. * Are scheduled for planned interventions requiring hospitalization \> 1 week. * Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to PD therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located. * Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months. * Have a history of non-compliance with HD as assessed by an investigator. * Have had a major cardiovascular or cerebrovascular event within 3 months of study entry. * Have a history with consistent evidence of intradialytic hypotension. * Have uncontrolled (systolic BP \> 180 mmHg) hypertension. * Have had adverse reactions to dialyzer materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 | Week 24 | FLC=free light chains |
| Pre-dialysis Serum Level of Albumin at Week 24 | Week 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | Week 4 and Week 24 | FLC=free light chains |
| Reduction Ratio of Complement Factor D | Week 4 and 24 | CFD=complement factor D |
| Reduction Ratio of κ FLC | Week 4 and 24 | κ FLC = Kappa Free light chains |
| Reduction Ratio of Interleukin 6 | Week 4 and 24 | IL-6=interleukin 6 |
| Reduction Ratio of Tumor Necrosis Factor Alpha | Week 4 and 24 | TNFα=tumor necrosis factor alpha |
| Reduction Ratio of β2-microglobulin | Week 4 and 24 | β2=beta 2 |
| Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 | Baseline, Week 24 | — |
| Kt/Vurea | Week 4, 8, 12, 16, 20, 24 | Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy. |
| Change From Baseline in Pre-dialysis Serum Albumin by Visit | Baseline, Week 4, 8, 12, 16, 20, 24 | — |
| Change From Baseline in Pre-dialysis Factor VII by Visit | Baseline, Week 12, Week 24 | — |
| Change From Baseline in Pre-dialysis Protein C by Visit | Baseline, Week 12, Week 24 | — |
| Change From Baseline in Pre-dialysis Vitamin A by Visit | Baseline, Week 4, Week 24 | — |
| nPNA (nPCR) | Week 4, 8, 12, 16, 20, 24 | nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate. |
| Change From Baseline in Pre-dialysis Factor II by Visit | Baseline, Week 12, Week 24 | Factor II (Prothrombin) |
| Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) | Baseline and Week 24 | — |
| Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) | Baseline and Week 24 | — |
| Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Platelets at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Erythrocytes at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Leukocytes at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Basophils (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Monocytes (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Kt/Vurea by Visit | Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | — |
| Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Protein (g/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24) | Baseline, Week 24 | — |
| Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) | Baseline, Week 24 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| 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. | 86 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Change to another dialysis center | 2 | 2 |
| Overall Study | Death | 3 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Miscellaneous | 2 | 2 |
| Overall Study | Missing 3 consecutive study treatments | 5 | 6 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Renal transplantation | 2 | 0 |
| Overall Study | Switch to peritoneal dialysis | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Theranova 400 | Elisio-17H | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 13.52 | 59.7 years STANDARD_DEVIATION 12.4 | 59.1 years STANDARD_DEVIATION 12.95 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 33 Participants | 35 Participants | 68 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 42 Participants | 82 Participants |
| Region of Enrollment United States | 86 Participants | 86 Participants | 172 Participants |
| Sex: Female, Male Female | 32 Participants | 35 Participants | 67 Participants |
| Sex: Female, Male Male | 54 Participants | 51 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 86 | 3 / 85 |
| other Total, other adverse events | 14 / 86 | 11 / 85 |
| serious Total, serious adverse events | 15 / 86 | 23 / 85 |
Outcome results
Primary
Pre-dialysis Serum Level of Albumin at Week 24
Time frame: Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Pre-dialysis Serum Level of Albumin at Week 24 | 4.030 g/dL | Standard Deviation 0.2843 |
| Elisio-17H | Pre-dialysis Serum Level of Albumin at Week 24 | 4.018 g/dL | Standard Deviation 0.3935 |
95% CI: [-0.098, 0.069]ANCOVA
Primary
Reduction Ratio of Lambda Immunoglobulin FLC at Week 24
FLC=free light chains
Time frame: Week 24
Population: Full Analysis Set. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 | 32.156 percentage ratio | Standard Deviation 12.602 |
| Elisio-17H | Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 | 17.514 percentage ratio | Standard Deviation 12.7235 |
Comparison: If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.95% CI: [10.501, 19.156]
Secondary
Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) | -0.82 Sec | Standard Deviation 16.682 |
| Elisio-17H | Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) | -0.96 Sec | Standard Deviation 15.424 |
p-value: 0.5067ANCOVA
Secondary
Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) | -2.17 U/L | Standard Deviation 8.168 |
| Elisio-17H | Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) | -0.51 U/L | Standard Deviation 8.018 |
p-value: 0.3042ANCOVA
Secondary
Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) | 0.01 g/dL | Standard Deviation 0.25 |
| Elisio-17H | Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) | 0.04 g/dL | Standard Deviation 0.256 |
p-value: 0.4513ANCOVA
Secondary
Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) | -1.97 U/L | Standard Deviation 37.783 |
| Elisio-17H | Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) | 2.19 U/L | Standard Deviation 32.725 |
p-value: 0.5326ANCOVA
Secondary
Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) | -0.75 U/L | Standard Deviation 6.816 |
| Elisio-17H | Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) | -0.01 U/L | Standard Deviation 5.87 |
p-value: 0.5534ANCOVA
Secondary
Change From Baseline in Basophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Basophils (%) at End of Study (up to Week 24) | -0.02 % of total white blood count (WBC) | Standard Deviation 0.408 |
p-value: 0.1925ANCOVA
Secondary
Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24) | -1.16 mg/L | Standard Deviation 6.128 |
p-value: 0.1824ANCOVA
Secondary
Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) | 1.31 mmol/L | Standard Deviation 3.053 |
| Elisio-17H | Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) | 1.37 mmol/L | Standard Deviation 3.08 |
p-value: 0.8413ANCOVA
Secondary
Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) | -1.06 μmol/L | Standard Deviation 2.96 |
| Elisio-17H | Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) | -0.66 μmol/L | Standard Deviation 2.04 |
p-value: 0.0998ANCOVA
Secondary
Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) | 0.33 no unit | Standard Deviation 9.298 |
| Elisio-17H | Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) | 0.68 no unit | Standard Deviation 8.963 |
p-value: 0.9672ANCOVA
Secondary
Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) | -0.06 mmol/L | Standard Deviation 0.154 |
| Elisio-17H | Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) | -0.02 mmol/L | Standard Deviation 0.151 |
p-value: 0.034ANCOVA
Secondary
Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) | 0.09 mmol/L | Standard Deviation 3.488 |
| Elisio-17H | Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) | 0.43 mmol/L | Standard Deviation 4.108 |
p-value: 0.9069ANCOVA
Secondary
Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) | -0.19 mmol/L | Standard Deviation 0.766 |
| Elisio-17H | Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) | -0.24 mmol/L | Standard Deviation 0.705 |
p-value: 0.7189ANCOVA
Secondary
Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24) | 1.89 mcg/mL | Standard Deviation 4.838 |
p-value: 0.0957ANCOVA
Secondary
Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) | -17.45 μmol/L | Standard Deviation 160.343 |
| Elisio-17H | Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) | -36.44 μmol/L | Standard Deviation 153.168 |
p-value: 0.2697ANCOVA
Secondary
Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) | 1.53 μmol/L | Standard Deviation 2.603 |
| Elisio-17H | Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) | 0.23 μmol/L | Standard Deviation 1.107 |
p-value: 0.2958ANCOVA
Secondary
Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) | 0.17 % of total WBC | Standard Deviation 3.259 |
| Elisio-17H | Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) | -0.29 % of total WBC | Standard Deviation 2.397 |
p-value: 0.2569ANCOVA
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) | -0.12 pg | Standard Deviation 1.079 |
| Elisio-17H | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) | -0.35 pg | Standard Deviation 1.153 |
p-value: 0.2304ANCOVA
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24) | -15.12 g/L | Standard Deviation 21.075 |
p-value: 0.5785ANCOVA
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) | 4.88 fL | Standard Deviation 5.371 |
| Elisio-17H | Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) | 1.93 fL | Standard Deviation 4.778 |
p-value: 0.0067ANCOVA
Secondary
Change From Baseline in Erythrocytes at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Erythrocytes at End of Study (up to Week 24) | 0.10 10^12 cells/L | Standard Deviation 0.482 |
| Elisio-17H | Change From Baseline in Erythrocytes at End of Study (up to Week 24) | 0.04 10^12 cells/L | Standard Deviation 0.365 |
p-value: 0.3281ANCOVA
Secondary
Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) | 0.38 percentage activity | Standard Deviation 34.572 |
| Elisio-17H | Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) | 9.19 percentage activity | Standard Deviation 48.575 |
p-value: 0.0769ANCOVA
Secondary
Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) | 0.14 percentage activity | Standard Deviation 19.376 |
| Elisio-17H | Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) | -1.78 percentage activity | Standard Deviation 18.781 |
p-value: 0.5992ANCOVA
Secondary
Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24) | -1.68 U/L | Standard Deviation 21.724 |
p-value: 0.9952ANCOVA
Secondary
Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) | -2.07 g/L | Standard Deviation 3.635 |
| Elisio-17H | Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) | -1.27 g/L | Standard Deviation 3.216 |
p-value: 0.1098ANCOVA
Secondary
Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) | -0.20 mmol/L | Standard Deviation 2.197 |
| Elisio-17H | Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) | 0.47 mmol/L | Standard Deviation 2.858 |
p-value: 0.0125ANCOVA
Secondary
Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) | 0.04 mmol/L | Standard Deviation 0.266 |
| Elisio-17H | Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) | -0.03 mmol/L | Standard Deviation 0.276 |
p-value: 0.097ANCOVA
Secondary
Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) | 0.03 L/L | Standard Deviation 0.055 |
| Elisio-17H | Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) | 0.01 L/L | Standard Deviation 0.042 |
p-value: 0.0297ANCOVA
Secondary
Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) | 2.74 g/L | Standard Deviation 15.569 |
| Elisio-17H | Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) | -0.11 g/L | Standard Deviation 11.221 |
p-value: 0.1325ANCOVA
Secondary
Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24) | -0.40 mg/L | Standard Deviation 4.6 |
p-value: 0.0766ANCOVA
Secondary
Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) | 0.20 pg/mL | Standard Deviation 5.449 |
| Elisio-17H | Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) | 1.64 pg/mL | Standard Deviation 6.473 |
p-value: 0.1825ANCOVA
Secondary
Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24) | -43.01 mg/L | Standard Deviation 75.677 |
p-value: 0.0012ANCOVA
Secondary
Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24) | 1.75 mg/L | Standard Deviation 29.946 |
p-value: 0.0002ANCOVA
Secondary
Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) | -0.07 mmol/L | Standard Deviation 0.663 |
| Elisio-17H | Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) | -0.18 mmol/L | Standard Deviation 0.807 |
p-value: 0.4513ANCOVA
Secondary
Change From Baseline in Leukocytes at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Leukocytes at End of Study (up to Week 24) | -0.22 10^9 cells/L | Standard Deviation 1.64 |
| Elisio-17H | Change From Baseline in Leukocytes at End of Study (up to Week 24) | 0.49 10^9 cells/L | Standard Deviation 2.464 |
p-value: 0.0463ANCOVA
Secondary
Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) | 0.14 % of total WBC | Standard Deviation 6.979 |
| Elisio-17H | Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) | -0.69 % of total WBC | Standard Deviation 8.052 |
p-value: 0.5709ANCOVA
Secondary
Change From Baseline in Monocytes (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Monocytes (%) at End of Study (up to Week 24) | -0.49 % of total WBC | Standard Deviation 2.261 |
| Elisio-17H | Change From Baseline in Monocytes (%) at End of Study (up to Week 24) | -1.07 % of total WBC | Standard Deviation 3.479 |
p-value: 0.217ANCOVA
Secondary
Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) | 0.16 % of total WBC | Standard Deviation 8.744 |
| Elisio-17H | Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) | 1.98 % of total WBC | Standard Deviation 9.485 |
p-value: 0.2386ANCOVA
Secondary
Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) | -0.03 mmol/L | Standard Deviation 0.438 |
| Elisio-17H | Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) | -0.19 mmol/L | Standard Deviation 0.5 |
p-value: 0.0285ANCOVA
Secondary
Change From Baseline in Platelets at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Platelets at End of Study (up to Week 24) | -8.65 10^9 cells/L | Standard Deviation 41.711 |
| Elisio-17H | Change From Baseline in Platelets at End of Study (up to Week 24) | 7.99 10^9 cells/L | Standard Deviation 49.215 |
p-value: 0.0434ANCOVA
Secondary
Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 2.36 |
| Elisio-17H | Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | -0.57 mmol urea/L | Standard Deviation 2.066 |
p-value: 0.8102ANCOVA
Secondary
Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline and Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) | 0.08 mmol/L | Standard Deviation 0.727 |
| Elisio-17H | Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) | -0.23 mmol/L | Standard Deviation 0.665 |
p-value: 0.0058ANCOVA
Secondary
Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | -0.69 mmol urea/L | Standard Deviation 4.784 |
p-value: 0.1769ANCOVA
Secondary
Change From Baseline in Pre-dialysis Factor II by Visit
Factor II (Prothrombin)
Time frame: Baseline, Week 12, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis Factor II by Visit | Week 12 | 3.45 percent activity | Standard Deviation 11.507 |
| Theranova 400 | Change From Baseline in Pre-dialysis Factor II by Visit | Week 24 | 3.85 percent activity | Standard Deviation 11.678 |
| Elisio-17H | Change From Baseline in Pre-dialysis Factor II by Visit | Week 12 | 3.19 percent activity | Standard Deviation 13.284 |
| Elisio-17H | Change From Baseline in Pre-dialysis Factor II by Visit | Week 24 | 5.78 percent activity | Standard Deviation 15.394 |
Comparison: Week 12p-value: 0.9001Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: 0.3279Mixed-effect Model Repeated Measurement
Secondary
Change From Baseline in Pre-dialysis Factor VII by Visit
Time frame: Baseline, Week 12, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis Factor VII by Visit | Week 24 | 0.38 percentage activity | Standard Deviation 34.572 |
| Theranova 400 | Change From Baseline in Pre-dialysis Factor VII by Visit | Week 12 | 3.59 percentage activity | Standard Deviation 24.057 |
| Elisio-17H | Change From Baseline in Pre-dialysis Factor VII by Visit | Week 24 | 9.19 percentage activity | Standard Deviation 48.575 |
| Elisio-17H | Change From Baseline in Pre-dialysis Factor VII by Visit | Week 12 | 7.79 percentage activity | Standard Deviation 27.798 |
Comparison: Week 12p-value: 0.1472Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: 0.1207Mixed-effect Model Repeated Measurement
Secondary
Change From Baseline in Pre-dialysis Protein C by Visit
Time frame: Baseline, Week 12, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis Protein C by Visit | Week 12 | 1.12 percentage activity | Standard Deviation 15.711 |
| Theranova 400 | Change From Baseline in Pre-dialysis Protein C by Visit | Week 24 | 0.14 percentage activity | Standard Deviation 19.376 |
| Elisio-17H | Change From Baseline in Pre-dialysis Protein C by Visit | Week 12 | 1.76 percentage activity | Standard Deviation 16.378 |
| Elisio-17H | Change From Baseline in Pre-dialysis Protein C by Visit | Week 24 | -1.78 percentage activity | Standard Deviation 18.781 |
Comparison: Week 12p-value: 0.9775Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: 0.5538Mixed-effect Model Repeated Measurement
Secondary
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 4 | -0.08 g/dL | Standard Deviation 0.244 |
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 8 | -0.11 g/dL | Standard Deviation 0.254 |
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 12 | -0.12 g/dL | Standard Deviation 0.289 |
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 16 | -0.13 g/dL | Standard Deviation 0.335 |
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 20 | -0.08 g/dL | Standard Deviation 0.279 |
| Theranova 400 | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 24 | 0.01 g/dL | Standard Deviation 0.25 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 20 | 0.02 g/dL | Standard Deviation 0.258 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 4 | 0 g/dL | Standard Deviation 0.203 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 16 | -0.03 g/dL | Standard Deviation 0.315 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 8 | 0.00 g/dL | Standard Deviation 0.216 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 24 | 0.04 g/dL | Standard Deviation 0.256 |
| Elisio-17H | Change From Baseline in Pre-dialysis Serum Albumin by Visit | Week 12 | -0.04 g/dL | Standard Deviation 0.229 |
Comparison: Week 4p-value: 0.0347Mixed-effect Model Repeated Measurement
Comparison: Week 8p-value: 0.0036Mixed-effect Model Repeated Measurement
Comparison: Week 12p-value: 0.129Mixed-effect Model Repeated Measurement
Comparison: Week 16p-value: 0.1149Mixed-effect Model Repeated Measurement
Comparison: Week 20p-value: 0.0688Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: 0.6097Mixed-effect Model Repeated Measurement
Secondary
Change From Baseline in Pre-dialysis Vitamin A by Visit
Time frame: Baseline, Week 4, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis Vitamin A by Visit | Week 4 | -0.29 μmol/L | Standard Deviation 0.983 |
| Theranova 400 | Change From Baseline in Pre-dialysis Vitamin A by Visit | Week 24 | -0.33 μmol/L | Standard Deviation 0.832 |
| Elisio-17H | Change From Baseline in Pre-dialysis Vitamin A by Visit | Week 4 | -0.04 μmol/L | Standard Deviation 0.939 |
| Elisio-17H | Change From Baseline in Pre-dialysis Vitamin A by Visit | Week 24 | -0.15 μmol/L | Standard Deviation 1.096 |
Comparison: Week 4p-value: 0.11Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: 0.4607Mixed-effect Model Repeated Measurement
Secondary
Change From Baseline in Pre-dialysis β2-microglobulin at Week 24
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 | -3.95 mg/L | Standard Deviation 5.614 |
| Elisio-17H | Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 | -1.16 mg/L | Standard Deviation 6.128 |
Secondary
Change From Baseline in Protein (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Protein (g/L) at End of Study (up to Week 24) | -1.55 g/L | Standard Deviation 4.576 |
| Elisio-17H | Change From Baseline in Protein (g/L) at End of Study (up to Week 24) | -0.95 g/L | Standard Deviation 4.223 |
p-value: 0.3063ANCOVA
Secondary
Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) | 3.85 percentage activity | Standard Deviation 11.678 |
| Elisio-17H | Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) | 5.78 percentage activity | Standard Deviation 15.394 |
p-value: 0.2886ANCOVA
Secondary
Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) | -0.01 ratio | Standard Deviation 0.341 |
| Elisio-17H | Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) | -0.05 ratio | Standard Deviation 0.527 |
p-value: 0.6043ANCOVA
Secondary
Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) | -0.04 Sec | Standard Deviation 4.016 |
| Elisio-17H | Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) | -0.49 Sec | Standard Deviation 6.305 |
p-value: 0.6891ANCOVA
Secondary
Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline and Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) | -0.20 mmol/L | Standard Deviation 3.192 |
| Elisio-17H | Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) | 0.00 mmol/L | Standard Deviation 3.671 |
p-value: 0.6576ANCOVA
Secondary
Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) | -0.15 mmol/L | Standard Deviation 0.661 |
| Elisio-17H | Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) | -0.02 mmol/L | Standard Deviation 0.672 |
p-value: 0.0733ANCOVA
Secondary
Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | 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 |
| Elisio-17H | Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24) | 0.08 pg/mL | Standard Deviation 1.645 |
p-value: 0.3836ANCOVA
Secondary
Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Theranova 400 | Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) | -0.35 μmol/L | Standard Deviation 0.826 |
| Elisio-17H | Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) | -0.01 μmol/L | Standard Deviation 0.899 |
Secondary
Kt/Vurea
Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.
Time frame: Week 4, 8, 12, 16, 20, 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Kt/Vurea | Week 8 | 1.62 Kt/Vurea | Standard Deviation 0.288 |
| Theranova 400 | Kt/Vurea | Week 16 | 1.56 Kt/Vurea | Standard Deviation 0.268 |
| Theranova 400 | Kt/Vurea | Week 4 | 1.58 Kt/Vurea | Standard Deviation 0.266 |
| Theranova 400 | Kt/Vurea | Week 20 | 1.57 Kt/Vurea | Standard Deviation 0.297 |
| Theranova 400 | Kt/Vurea | Week 12 | 1.58 Kt/Vurea | Standard Deviation 0.294 |
| Theranova 400 | Kt/Vurea | Week 24 | 1.51 Kt/Vurea | Standard Deviation 0.31 |
| Elisio-17H | Kt/Vurea | Week 12 | 1.55 Kt/Vurea | Standard Deviation 0.328 |
| Elisio-17H | Kt/Vurea | Week 4 | 1.58 Kt/Vurea | Standard Deviation 0.427 |
| Elisio-17H | Kt/Vurea | Week 8 | 1.51 Kt/Vurea | Standard Deviation 0.316 |
| Elisio-17H | Kt/Vurea | Week 24 | 1.54 Kt/Vurea | Standard Deviation 0.467 |
| Elisio-17H | Kt/Vurea | Week 16 | 1.59 Kt/Vurea | Standard Deviation 0.48 |
| Elisio-17H | Kt/Vurea | Week 20 | 1.55 Kt/Vurea | Standard Deviation 0.371 |
Secondary
Kt/Vurea by Visit
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Kt/Vurea by Visit | Week 4 | 1.58 no unit | Standard Deviation 0.266 |
| Theranova 400 | Kt/Vurea by Visit | Week 8 | 1.62 no unit | Standard Deviation 0.288 |
| Theranova 400 | Kt/Vurea by Visit | Week 12 | 1.58 no unit | Standard Deviation 0.294 |
| Theranova 400 | Kt/Vurea by Visit | Week 16 | 1.56 no unit | Standard Deviation 0.268 |
| Theranova 400 | Kt/Vurea by Visit | Week 20 | 1.57 no unit | Standard Deviation 0.297 |
| Theranova 400 | Kt/Vurea by Visit | Week 24 | 1.51 no unit | Standard Deviation 0.31 |
| Elisio-17H | Kt/Vurea by Visit | Week 20 | 1.55 no unit | Standard Deviation 0.371 |
| Elisio-17H | Kt/Vurea by Visit | Week 4 | 1.58 no unit | Standard Deviation 0.427 |
| Elisio-17H | Kt/Vurea by Visit | Week 16 | 1.59 no unit | Standard Deviation 0.48 |
| Elisio-17H | Kt/Vurea by Visit | Week 8 | 1.51 no unit | Standard Deviation 0.316 |
| Elisio-17H | Kt/Vurea by Visit | Week 24 | 1.54 no unit | Standard Deviation 0.467 |
| Elisio-17H | Kt/Vurea by Visit | Week 12 | 1.55 no unit | Standard Deviation 0.328 |
Secondary
nPNA (nPCR)
nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.
Time frame: Week 4, 8, 12, 16, 20, 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | nPNA (nPCR) | Week 16 | 1.022 g/kg/d | Standard Deviation 0.2869 |
| Theranova 400 | nPNA (nPCR) | Week 4 | 0.983 g/kg/d | Standard Deviation 0.2473 |
| Theranova 400 | nPNA (nPCR) | Week 20 | 0.988 g/kg/d | Standard Deviation 0.2666 |
| Theranova 400 | nPNA (nPCR) | Week 12 | 0.971 g/kg/d | Standard Deviation 0.2573 |
| Theranova 400 | nPNA (nPCR) | Week 24 | 0.947 g/kg/d | Standard Deviation 0.245 |
| Theranova 400 | nPNA (nPCR) | Week 8 | 1.013 g/kg/d | Standard Deviation 0.238 |
| Elisio-17H | nPNA (nPCR) | Week 24 | 1.012 g/kg/d | Standard Deviation 0.2891 |
| Elisio-17H | nPNA (nPCR) | Week 8 | 1.023 g/kg/d | Standard Deviation 0.2936 |
| Elisio-17H | nPNA (nPCR) | Week 12 | 1.030 g/kg/d | Standard Deviation 0.2664 |
| Elisio-17H | nPNA (nPCR) | Week 16 | 0.971 g/kg/d | Standard Deviation 0.2881 |
| Elisio-17H | nPNA (nPCR) | Week 20 | 1.024 g/kg/d | Standard Deviation 0.3366 |
| Elisio-17H | nPNA (nPCR) | Week 4 | 1.056 g/kg/d | Standard Deviation 0.3088 |
Comparison: Week 24p-value: 0.1497Mixed-effect Model Repeated Measurement
Comparison: Week 4p-value: 0.0791Mixed-effect Model Repeated Measurement
Comparison: Week 8p-value: 0.9505Mixed-effect Model Repeated Measurement
Comparison: Week 12p-value: 0.1521Mixed-effect Model Repeated Measurement
Comparison: Week 16p-value: 0.2489Mixed-effect Model Repeated Measurement
Comparison: Week 20p-value: 0.4936Mixed-effect Model Repeated Measurement
Secondary
Reduction Ratio of Complement Factor D
CFD=complement factor D
Time frame: Week 4 and 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of Complement Factor D | Week 4 | 36.78 percentage ratio | Standard Deviation 26.499 |
| Theranova 400 | Reduction Ratio of Complement Factor D | Week 24 | 38.09 percentage ratio | Standard Deviation 11.233 |
| Elisio-17H | Reduction Ratio of Complement Factor D | Week 4 | 11.71 percentage ratio | Standard Deviation 27.71 |
| Elisio-17H | Reduction Ratio of Complement Factor D | Week 24 | 14.55 percentage ratio | Standard Deviation 11.298 |
Comparison: Week 4p-value: <0.0001MMRM
Comparison: Week 24p-value: <0.0001MMRM
Secondary
Reduction Ratio of Interleukin 6
IL-6=interleukin 6
Time frame: Week 4 and 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of Interleukin 6 | Week 4 | -4.62 percentage ratio | Standard Deviation 49.378 |
| Theranova 400 | Reduction Ratio of Interleukin 6 | Week 24 | -0.85 percentage ratio | Standard Deviation 46.214 |
| Elisio-17H | Reduction Ratio of Interleukin 6 | Week 4 | -22.21 percentage ratio | Standard Deviation 69.618 |
| Elisio-17H | Reduction Ratio of Interleukin 6 | Week 24 | -14.83 percentage ratio | Standard Deviation 43.574 |
Comparison: Week 4p-value: 0.0684MMRM
Comparison: Week 24p-value: 0.0806MMRM
Secondary
Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
FLC=free light chains
Time frame: Week 4 and Week 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | Week 4 | 39.3 percentage ratio | Standard Deviation 14.487 |
| Theranova 400 | Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | Week 24 | 33.29 percentage ratio | Standard Deviation 10.96 |
| Elisio-17H | Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | Week 4 | 19.88 percentage ratio | Standard Deviation 11.394 |
| Elisio-17H | Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | Week 24 | 17.19 percentage ratio | Standard Deviation 12.863 |
Comparison: Week 4p-value: <0.0001Mixed-effect Model Repeated Measurement
Comparison: Week 24p-value: <0.0001Mixed-effect Model Repeated Measurement
Secondary
Reduction Ratio of Tumor Necrosis Factor Alpha
TNFα=tumor necrosis factor alpha
Time frame: Week 4 and 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of Tumor Necrosis Factor Alpha | Week 4 | 47.29 percentage ratio | Standard Deviation 9.966 |
| Theranova 400 | Reduction Ratio of Tumor Necrosis Factor Alpha | Week 24 | 44.48 percentage ratio | Standard Deviation 10.215 |
| Elisio-17H | Reduction Ratio of Tumor Necrosis Factor Alpha | Week 4 | 37.9 percentage ratio | Standard Deviation 8.892 |
| Elisio-17H | Reduction Ratio of Tumor Necrosis Factor Alpha | Week 24 | 34.52 percentage ratio | Standard Deviation 10.673 |
Secondary
Reduction Ratio of β2-microglobulin
β2=beta 2
Time frame: Week 4 and 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of β2-microglobulin | Week 4 | 75.67 percentage ratio | Standard Deviation 8.2 |
| Theranova 400 | Reduction Ratio of β2-microglobulin | Week 24 | 73.64 percentage ratio | Standard Deviation 10.426 |
| Elisio-17H | Reduction Ratio of β2-microglobulin | Week 4 | 64.86 percentage ratio | Standard Deviation 8.903 |
| Elisio-17H | Reduction Ratio of β2-microglobulin | Week 24 | 65.41 percentage ratio | Standard Deviation 9.428 |
Secondary
Reduction Ratio of κ FLC
κ FLC = Kappa Free light chains
Time frame: Week 4 and 24
Population: FAS. Number of subjects (n) with evaluable data is shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Theranova 400 | Reduction Ratio of κ FLC | Week 4 | 65.63 percentage ratio | Standard Deviation 18.566 |
| Theranova 400 | Reduction Ratio of κ FLC | Week 24 | 59.27 percentage ratio | Standard Deviation 13.068 |
| Elisio-17H | Reduction Ratio of κ FLC | Week 4 | 49.74 percentage ratio | Standard Deviation 15.111 |
| Elisio-17H | Reduction Ratio of κ FLC | Week 24 | 43.91 percentage ratio | Standard Deviation 14.882 |
Comparison: Week 4p-value: <0.0001MMRM
Comparison: Week 24p-value: <0.0001MMRM