<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257410</url>
  </required_header>
  <id_info>
    <org_study_id>7905001</org_study_id>
    <nct_id>NCT03257410</nct_id>
  </id_info>
  <brief_title>Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients</brief_title>
  <official_title>A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baxter Healthcare Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with&#xD;
      Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment.&#xD;
      Efficacy will be determined by the removal of middle molecules (with different molecular&#xD;
      size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum&#xD;
      albumin levels and other safety events including laboratory tests and adverse events.&#xD;
&#xD;
      Patients will undergo 3 dialysis sessions per week, for 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">October 27, 2018</completion_date>
  <primary_completion_date type="Actual">October 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction Ratio of Lambda Immunoglobulin FLC at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>FLC=free light chains</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-dialysis Serum Level of Albumin at Week 24</measure>
    <time_frame>Week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24</measure>
    <time_frame>Week 4 and Week 24</time_frame>
    <description>FLC=free light chains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of Complement Factor D</measure>
    <time_frame>Week 4 and 24</time_frame>
    <description>CFD=complement factor D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of κ FLC</measure>
    <time_frame>Week 4 and 24</time_frame>
    <description>κ FLC = Kappa Free light chains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of Interleukin 6</measure>
    <time_frame>Week 4 and 24</time_frame>
    <description>IL-6=interleukin 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of Tumor Necrosis Factor Alpha</measure>
    <time_frame>Week 4 and 24</time_frame>
    <description>TNFα=tumor necrosis factor alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction Ratio of β2-microglobulin</measure>
    <time_frame>Week 4 and 24</time_frame>
    <description>β2=beta 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis β2-microglobulin at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kt/Vurea</measure>
    <time_frame>Week 4, 8, 12, 16, 20, 24</time_frame>
    <description>Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis Serum Albumin by Visit</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis Factor VII by Visit</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis Protein C by Visit</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis Vitamin A by Visit</measure>
    <time_frame>Baseline, Week 4, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nPNA (nPCR)</measure>
    <time_frame>Week 4, 8, 12, 16, 20, 24</time_frame>
    <description>nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dialysis Factor II by Visit</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>Factor II (Prothrombin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Platelets at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocytes at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leukocytes at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Basophils (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monocytes (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kt/Vurea by Visit</measure>
    <time_frame>Week 4, Week 8, Week 12, Week 16, Week 20, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Protein (g/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Theranova 400</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elisio-17H</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Theranova 400 dialyzer</intervention_name>
    <description>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.</description>
    <arm_group_label>Theranova 400</arm_group_label>
    <other_name>MCO-Ci 400 Dialyzer</other_name>
    <other_name>medium cut-off dialysis membrane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elisio-17H dialyzer</intervention_name>
    <description>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.</description>
    <arm_group_label>Elisio-17H</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.&#xD;
&#xD;
          -  Clinically stable as judged by the treating physician and as demonstrated by stable&#xD;
             medical history for 30 days prior to enrollment, physical examination, and laboratory&#xD;
             testing.&#xD;
&#xD;
          -  Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior&#xD;
             to study enrollment and expected to survive for the next 12 months.&#xD;
&#xD;
          -  Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an&#xD;
             approximate surface area of 1.7 m2.&#xD;
&#xD;
          -  Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.&#xD;
&#xD;
          -  Able to give informed consent after an explanation of the proposed study, and who are&#xD;
             willing to comply with the study requirements for therapy during the entire study&#xD;
             treatment period.&#xD;
&#xD;
          -  Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen&#xD;
             tunneled catheter); stable access will be confirmed by observed Kt/V &gt;= 1.2 for past 2&#xD;
             measurements, and/or achievement of within 15% the prescribed blood flow rate over 3&#xD;
             treatments prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are female and pregnant, lactating, or planning to become pregnant during the study&#xD;
             period. Note: Female subjects of childbearing potential, defined as a woman &lt;55 years&#xD;
             old who has not had a partial or full hysterectomy or oophorectomy, must have a&#xD;
             negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening.&#xD;
             Subjects of childbearing potential must use a medically acceptable means of&#xD;
             contraception during their participation in the study.&#xD;
&#xD;
          -  Have chronic liver disease.&#xD;
&#xD;
          -  Have a known paraprotein-associated disease.&#xD;
&#xD;
          -  Have known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small&#xD;
             bowel angiodysplasia, and active peptic ulcers).&#xD;
&#xD;
          -  Have had a major bleeding episode (i.e. soft tissue bleeding, blood in stool,&#xD;
             prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding,&#xD;
             exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to randomization.&#xD;
&#xD;
          -  Have had a blood (red blood cell) transfusion ≤ 12 weeks prior to randomization.&#xD;
&#xD;
          -  Have had an acute infection ≤ 4 weeks prior to randomization.&#xD;
&#xD;
          -  Have active cancer, except for basal cell or squamous cell skin cancer.&#xD;
&#xD;
          -  Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1.b&#xD;
&#xD;
          -  Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance,&#xD;
             smoldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma,&#xD;
             plasmacytomas, or plasma cell leukemia).&#xD;
&#xD;
          -  Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic&#xD;
             infection, lymphoproliferative disorder, or other hematologic condition).&#xD;
&#xD;
          -  Have a positive serology test for human immunodeficiency virus or hepatitis infection.&#xD;
&#xD;
          -  Have a significant psychiatric disorder or mental disability.&#xD;
&#xD;
          -  Are scheduled for planned interventions requiring hospitalization &gt; 1 week.&#xD;
&#xD;
          -  Are scheduled for living-donor transplantation within the study period + 3 months,&#xD;
             plan to change to PD therapy within the next 9 months, plan to change to a home&#xD;
             hemodialysis treatment, or plan to relocate to an area where no study center is&#xD;
             located.&#xD;
&#xD;
          -  Are currently participating in another interventional clinical study or has&#xD;
             participated in another interventional clinical study in the past 3 months.&#xD;
&#xD;
          -  Have a history of non-compliance with HD as assessed by an investigator.&#xD;
&#xD;
          -  Have had a major cardiovascular or cerebrovascular event within 3 months of study&#xD;
             entry.&#xD;
&#xD;
          -  Have a history with consistent evidence of intradialytic hypotension.&#xD;
&#xD;
          -  Have uncontrolled (systolic BP &gt; 180 mmHg) hypertension.&#xD;
&#xD;
          -  Have had adverse reactions to dialyzer materials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DaVita Corona</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92881</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Riverside</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc, Greater Hartford Nephrology</name>
      <address>
        <city>Bloomfield</city>
        <state>Connecticut</state>
        <zip>06002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Waterbury Dialysis</name>
      <address>
        <city>Middlebury</city>
        <state>Connecticut</state>
        <zip>06762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. Albany</name>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <zip>31701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. Kidney Associates of Kansas City</name>
      <address>
        <city>Belton</city>
        <state>Missouri</state>
        <zip>64012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center of Lincoln</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Five Star Dialysis Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., South Las Vegas Dialysis</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. North Brunswick</name>
      <address>
        <city>North Brunswick</city>
        <state>New Jersey</state>
        <zip>08902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Bronx Dialysis Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. Philidelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Center, Inc. Holston River Clinic</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37924</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Transmountain Dialysis</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Medical Center Dialysis</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Renal Center of Lewisville</name>
      <address>
        <city>Lewisville</city>
        <state>Texas</state>
        <zip>75057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Northwest Medical Center Dialysis</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Floyd Curl Dialysis</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Inc., Norfolk Dialysis</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cjasn.asnjournals.org/content/15/9/1310</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Weiner DE, Falzon L, Skoufos L, Bernardo A, Beck W, Xiao M, Tran H. Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1310-1319. doi: 10.2215/CJN.01210120. Epub 2020 Aug 25.</citation>
    <PMID>32843372</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>October 1, 2020</results_first_submitted>
  <results_first_submitted_qc>November 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2020</results_first_posted>
  <disposition_first_submitted>November 9, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>November 24, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 19, 2020</disposition_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03257410/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03257410/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Theranova 400</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
        <group group_id="P2">
          <title>Elisio-17H</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Renal transplantation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Switch to peritoneal dialysis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Change to another dialysis center</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing 3 consecutive study treatments</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Theranova 400</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
        <group group_id="B2">
          <title>Elisio-17H</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="86"/>
            <count group_id="B2" value="86"/>
            <count group_id="B3" value="172"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.5" spread="13.52"/>
                    <measurement group_id="B2" value="59.7" spread="12.4"/>
                    <measurement group_id="B3" value="59.1" spread="12.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Reduction Ratio of Lambda Immunoglobulin FLC at Week 24</title>
        <description>FLC=free light chains</description>
        <time_frame>Week 24</time_frame>
        <population>Full Analysis Set. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of Lambda Immunoglobulin FLC at Week 24</title>
          <description>FLC=free light chains</description>
          <population>Full Analysis Set. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.156" spread="12.602"/>
                    <measurement group_id="O2" value="17.514" spread="12.7235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is &gt; 0 then superiority will be demonstrated.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>14.828</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.501</ci_lower_limit>
            <ci_upper_limit>19.156</ci_upper_limit>
            <estimate_desc>Method=ANCOVA</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pre-dialysis Serum Level of Albumin at Week 24</title>
        <time_frame>Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dialysis Serum Level of Albumin at Week 24</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.030" spread="0.2843"/>
                    <measurement group_id="O2" value="4.018" spread="0.3935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is &gt; -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is &gt; 0, then superiority may be concluded.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.015</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.098</ci_lower_limit>
            <ci_upper_limit>0.069</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24</title>
        <description>FLC=free light chains</description>
        <time_frame>Week 4 and Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24</title>
          <description>FLC=free light chains</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" spread="14.487"/>
                    <measurement group_id="O2" value="19.88" spread="11.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.29" spread="10.96"/>
                    <measurement group_id="O2" value="17.19" spread="12.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>19.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.103</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>16.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.115</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of Complement Factor D</title>
        <description>CFD=complement factor D</description>
        <time_frame>Week 4 and 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of Complement Factor D</title>
          <description>CFD=complement factor D</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.78" spread="26.499"/>
                    <measurement group_id="O2" value="11.71" spread="27.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.09" spread="11.233"/>
                    <measurement group_id="O2" value="14.55" spread="11.298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>25.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.300</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>23.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.000</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of κ FLC</title>
        <description>κ FLC = Kappa Free light chains</description>
        <time_frame>Week 4 and 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of κ FLC</title>
          <description>κ FLC = Kappa Free light chains</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.63" spread="18.566"/>
                    <measurement group_id="O2" value="49.74" spread="15.111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.27" spread="13.068"/>
                    <measurement group_id="O2" value="43.91" spread="14.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>15.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.730</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>15.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.479</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of Interleukin 6</title>
        <description>IL-6=interleukin 6</description>
        <time_frame>Week 4 and 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of Interleukin 6</title>
          <description>IL-6=interleukin 6</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.62" spread="49.378"/>
                    <measurement group_id="O2" value="-22.21" spread="69.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="46.214"/>
                    <measurement group_id="O2" value="-14.83" spread="43.574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0684</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>17.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.583</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0806</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>13.98</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.937</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of Tumor Necrosis Factor Alpha</title>
        <description>TNFα=tumor necrosis factor alpha</description>
        <time_frame>Week 4 and 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of Tumor Necrosis Factor Alpha</title>
          <description>TNFα=tumor necrosis factor alpha</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.29" spread="9.966"/>
                    <measurement group_id="O2" value="37.9" spread="8.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.48" spread="10.215"/>
                    <measurement group_id="O2" value="34.52" spread="10.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction Ratio of β2-microglobulin</title>
        <description>β2=beta 2</description>
        <time_frame>Week 4 and 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction Ratio of β2-microglobulin</title>
          <description>β2=beta 2</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.67" spread="8.2"/>
                    <measurement group_id="O2" value="64.86" spread="8.903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.64" spread="10.426"/>
                    <measurement group_id="O2" value="65.41" spread="9.428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis β2-microglobulin at Week 24</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis β2-microglobulin at Week 24</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.95" spread="5.614"/>
                    <measurement group_id="O2" value="-1.16" spread="6.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kt/Vurea</title>
        <description>Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.</description>
        <time_frame>Week 4, 8, 12, 16, 20, 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Kt/Vurea</title>
          <description>Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>Kt/Vurea</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="0.266"/>
                    <measurement group_id="O2" value="1.58" spread="0.427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.288"/>
                    <measurement group_id="O2" value="1.51" spread="0.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="0.294"/>
                    <measurement group_id="O2" value="1.55" spread="0.328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.268"/>
                    <measurement group_id="O2" value="1.59" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.297"/>
                    <measurement group_id="O2" value="1.55" spread="0.371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" spread="0.31"/>
                    <measurement group_id="O2" value="1.54" spread="0.467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis Serum Albumin by Visit</title>
        <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis Serum Albumin by Visit</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.244"/>
                    <measurement group_id="O2" value="0" spread="0.203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.254"/>
                    <measurement group_id="O2" value="0.00" spread="0.216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.289"/>
                    <measurement group_id="O2" value="-0.04" spread="0.229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.335"/>
                    <measurement group_id="O2" value="-0.03" spread="0.315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.279"/>
                    <measurement group_id="O2" value="0.02" spread="0.258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.250"/>
                    <measurement group_id="O2" value="0.04" spread="0.256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0347</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.033</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0036</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.033</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.129</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.040</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1149</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.052</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 20</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0688</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.044</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6097</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.042</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis Factor VII by Visit</title>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis Factor VII by Visit</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="24.057"/>
                    <measurement group_id="O2" value="7.79" spread="27.798"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="34.572"/>
                    <measurement group_id="O2" value="9.19" spread="48.575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1472</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.336</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1207</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.154</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis Protein C by Visit</title>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis Protein C by Visit</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="15.711"/>
                    <measurement group_id="O2" value="1.76" spread="16.378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="19.376"/>
                    <measurement group_id="O2" value="-1.78" spread="18.781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9775</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.488</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5538</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.905</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis Vitamin A by Visit</title>
        <time_frame>Baseline, Week 4, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis Vitamin A by Visit</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="0.983"/>
                    <measurement group_id="O2" value="-0.04" spread="0.939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.832"/>
                    <measurement group_id="O2" value="-0.15" spread="1.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1100</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.146</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4607</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.153</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>nPNA (nPCR)</title>
        <description>nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.</description>
        <time_frame>Week 4, 8, 12, 16, 20, 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>nPNA (nPCR)</title>
          <description>nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/kg/d</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.983" spread="0.2473"/>
                    <measurement group_id="O2" value="1.056" spread="0.3088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.013" spread="0.2380"/>
                    <measurement group_id="O2" value="1.023" spread="0.2936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.971" spread="0.2573"/>
                    <measurement group_id="O2" value="1.030" spread="0.2664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.022" spread="0.2869"/>
                    <measurement group_id="O2" value="0.971" spread="0.2881"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.988" spread="0.2666"/>
                    <measurement group_id="O2" value="1.024" spread="0.3366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.947" spread="0.2450"/>
                    <measurement group_id="O2" value="1.012" spread="0.2891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0791</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0787</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04454</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9505</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0027</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04302</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1521</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0615</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04271</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2489</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0538</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04652</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 20</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4936</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0345</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05025</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1497</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0663</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04580</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dialysis Factor II by Visit</title>
        <description>Factor II (Prothrombin)</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dialysis Factor II by Visit</title>
          <description>Factor II (Prothrombin)</description>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percent activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.45" spread="11.507"/>
                    <measurement group_id="O2" value="3.19" spread="13.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" spread="11.678"/>
                    <measurement group_id="O2" value="5.78" spread="15.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9001</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.012</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3279</p_value>
            <method>Mixed-effect Model Repeated Measurement</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.372</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline and Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="3.192"/>
                    <measurement group_id="O2" value="0.00" spread="3.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6576</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.452</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline and Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.727"/>
                    <measurement group_id="O2" value="-0.23" spread="0.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0058</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.104</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.154"/>
                    <measurement group_id="O2" value="-0.02" spread="0.151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.023</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.438"/>
                    <measurement group_id="O2" value="-0.19" spread="0.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0285</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.071</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="3.488"/>
                    <measurement group_id="O2" value="0.43" spread="4.108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9069</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.513</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="3.053"/>
                    <measurement group_id="O2" value="1.37" spread="3.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8413</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.443</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="2.197"/>
                    <measurement group_id="O2" value="0.47" spread="2.858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0125</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.382</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>Sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="4.016"/>
                    <measurement group_id="O2" value="-0.49" spread="6.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6891</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.561</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.341"/>
                    <measurement group_id="O2" value="-0.05" spread="0.527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6043</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.047</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>Sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.82" spread="16.682"/>
                    <measurement group_id="O2" value="-0.96" spread="15.424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5067</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.080</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>L/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.055"/>
                    <measurement group_id="O2" value="0.01" spread="0.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0297</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.009</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" spread="15.569"/>
                    <measurement group_id="O2" value="-0.11" spread="11.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1325</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.140</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>pg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="1.079"/>
                    <measurement group_id="O2" value="-0.35" spread="1.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2304</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.186</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.54" spread="16.053"/>
                    <measurement group_id="O2" value="-15.12" spread="21.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5785</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.846</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>fL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.88" spread="5.371"/>
                    <measurement group_id="O2" value="1.93" spread="4.778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0067</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.918</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Platelets at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Platelets at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.65" spread="41.711"/>
                    <measurement group_id="O2" value="7.99" spread="49.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0434</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.93</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.314</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocytes at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocytes at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>10^12 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.482"/>
                    <measurement group_id="O2" value="0.04" spread="0.365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3281</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.070</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leukocytes at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leukocytes at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="1.640"/>
                    <measurement group_id="O2" value="0.49" spread="2.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0463</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.334</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Basophils (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Basophils (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>% of total white blood count (WBC)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.369"/>
                    <measurement group_id="O2" value="-0.02" spread="0.408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1925</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.060</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>% of total WBC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="3.259"/>
                    <measurement group_id="O2" value="-0.29" spread="2.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2569</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.389</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>% of total WBC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="6.979"/>
                    <measurement group_id="O2" value="-0.69" spread="8.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5709</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.104</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monocytes (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monocytes (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>% of total WBC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="2.261"/>
                    <measurement group_id="O2" value="-1.07" spread="3.479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.217</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.412</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>% of total WBC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="8.744"/>
                    <measurement group_id="O2" value="1.98" spread="9.485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2386</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.292</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol urea/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.82" spread="5.299"/>
                    <measurement group_id="O2" value="-0.69" spread="4.784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1769</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.840</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol urea/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="2.360"/>
                    <measurement group_id="O2" value="-0.57" spread="2.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8102</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.360</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>no unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="9.298"/>
                    <measurement group_id="O2" value="0.68" spread="8.963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9672</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.501</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.45" spread="160.343"/>
                    <measurement group_id="O2" value="-36.44" spread="153.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2697</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>27.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>24.623</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kt/Vurea by Visit</title>
        <time_frame>Week 4, Week 8, Week 12, Week 16, Week 20, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Kt/Vurea by Visit</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>no unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="0.266"/>
                    <measurement group_id="O2" value="1.58" spread="0.427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.288"/>
                    <measurement group_id="O2" value="1.51" spread="0.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="0.294"/>
                    <measurement group_id="O2" value="1.55" spread="0.328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.268"/>
                    <measurement group_id="O2" value="1.59" spread="0.480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.297"/>
                    <measurement group_id="O2" value="1.55" spread="0.371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" spread="0.310"/>
                    <measurement group_id="O2" value="1.54" spread="0.467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.826"/>
                    <measurement group_id="O2" value="-0.01" spread="0.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.766"/>
                    <measurement group_id="O2" value="-0.24" spread="0.705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7189</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.115</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.266"/>
                    <measurement group_id="O2" value="-0.03" spread="0.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.097</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.044</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.663"/>
                    <measurement group_id="O2" value="-0.18" spread="0.807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4513</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.113</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.661"/>
                    <measurement group_id="O2" value="-0.02" spread="0.672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0733</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.100</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.97" spread="37.783"/>
                    <measurement group_id="O2" value="2.19" spread="32.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5326</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.467</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.17" spread="8.168"/>
                    <measurement group_id="O2" value="-0.51" spread="8.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3042</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.076</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="6.816"/>
                    <measurement group_id="O2" value="-0.01" spread="5.870"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5534</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.976</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="2.603"/>
                    <measurement group_id="O2" value="0.23" spread="1.107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2958</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.181</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.06" spread="2.960"/>
                    <measurement group_id="O2" value="-0.66" spread="2.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0998</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.377</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="22.587"/>
                    <measurement group_id="O2" value="-1.68" spread="21.724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9952</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.176</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Protein (g/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Protein (g/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.55" spread="4.576"/>
                    <measurement group_id="O2" value="-0.95" spread="4.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3063</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.693</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.07" spread="3.635"/>
                    <measurement group_id="O2" value="-1.27" spread="3.216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1098</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.529</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" spread="4.168"/>
                    <measurement group_id="O2" value="-0.40" spread="4.600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0766</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.797</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" spread="11.678"/>
                    <measurement group_id="O2" value="5.78" spread="15.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2886</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.410</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.250"/>
                    <measurement group_id="O2" value="0.04" spread="0.256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4513</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.042</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="19.376"/>
                    <measurement group_id="O2" value="-1.78" spread="18.781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5992</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.960</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="1.999"/>
                    <measurement group_id="O2" value="0.08" spread="1.645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3836</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.290</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>percentage activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="34.572"/>
                    <measurement group_id="O2" value="9.19" spread="48.575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0769</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.284</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.40" spread="31.635"/>
                    <measurement group_id="O2" value="1.75" spread="29.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-19.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.170</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="5.449"/>
                    <measurement group_id="O2" value="1.64" spread="6.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1825</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.039</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="4.742"/>
                    <measurement group_id="O2" value="1.89" spread="4.838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0957</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.737</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-84.81" spread="97.359"/>
                    <measurement group_id="O2" value="-43.01" spread="75.677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-34.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.230</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
        <group_list>
          <group group_id="O1">
            <title>Theranova 400</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Elisio-17H</title>
            <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)</title>
          <population>FAS. Number of subjects (n) with evaluable data is shown.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.95" spread="5.614"/>
                    <measurement group_id="O2" value="-1.16" spread="6.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1824</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.859</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>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).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Theranova 400</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
        <group group_id="E2">
          <title>Elisio-17H</title>
          <description>Three (3) dialysis sessions per week in an in-center setting over 24-week period.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMORRHAGIC ANAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>ARTERIOSCLEROSIS CORONARY ARTERY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>BRADYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>UMBILICAL HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS CHRONIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>GRAFT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ARTERIOVENOUS FISTULA THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>MULTIPLE INJURIES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PATELLA FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>VASCULAR GRAFT COMPLICATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>CALCIPHYLAXIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>FLUID OVERLOAD</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>HYPERKALAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ANAL SQUAMOUS CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>MESOTHELIOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBRAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AORTIC STENOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERY STENOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>PROCEDURAL HYPOTENSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E2" events="17" subjects_affected="7" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Baxter Clinical Trials Disclosure Call Center</name_or_title>
      <organization>Baxter Healthcare</organization>
      <phone>(224) 948-7359</phone>
      <email>Global_CORP_ClinicalTrialsDisclosure@baxter.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257410
org study id: 7905001
nct id: NCT03257410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction Ratio of Lambda Immunoglobulin FLC at Week 24
time frame: Week 24
description: FLC=free light chains
measure: Pre-dialysis Serum Level of Albumin at Week 24
time frame: Week 24
measure: Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
time frame: Week 4 and Week 24
description: FLC=free light chains
measure: Reduction Ratio of Complement Factor D
time frame: Week 4 and 24
description: CFD=complement factor D
measure: Reduction Ratio of κ FLC
time frame: Week 4 and 24
description: κ FLC = Kappa Free light chains
measure: Reduction Ratio of Interleukin 6
time frame: Week 4 and 24
description: IL-6=interleukin 6
measure: Reduction Ratio of Tumor Necrosis Factor Alpha
time frame: Week 4 and 24
description: TNFα=tumor necrosis factor alpha
measure: Reduction Ratio of β2-microglobulin
time frame: Week 4 and 24
description: β2=beta 2
measure: Change From Baseline in Pre-dialysis β2-microglobulin at Week 24
time frame: Baseline, Week 24
measure: Kt/Vurea
time frame: Week 4, 8, 12, 16, 20, 24
description: Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.
measure: Change From Baseline in Pre-dialysis Serum Albumin by Visit
time frame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Change From Baseline in Pre-dialysis Factor VII by Visit
time frame: Baseline, Week 12, Week 24
measure: Change From Baseline in Pre-dialysis Protein C by Visit
time frame: Baseline, Week 12, Week 24
measure: Change From Baseline in Pre-dialysis Vitamin A by Visit
time frame: Baseline, Week 4, Week 24
measure: nPNA (nPCR)
time frame: Week 4, 8, 12, 16, 20, 24
description: nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.
measure: Change From Baseline in Pre-dialysis Factor II by Visit
time frame: Baseline, Week 12, Week 24
description: Factor II (Prothrombin)
measure: Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)
time frame: Baseline and Week 24
measure: Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)
time frame: Baseline and Week 24
measure: Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Platelets at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Erythrocytes at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Leukocytes at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Basophils (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Monocytes (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: 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
measure: 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
measure: Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Kt/Vurea by Visit
time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Protein (g/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
measure: Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)
time frame: Baseline, Week 24
arm group label: Theranova 400
arm group type: Experimental
description: Three (3) dialysis sessions per week in an in-center setting over 24-week period.
arm group label: Elisio-17H
arm group type: Active Comparator
description: Three (3) dialysis sessions per week in an in-center setting over 24-week period.
intervention type: Device
intervention name: Theranova 400 dialyzer
description: 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.
arm group label: Theranova 400
other name: MCO-Ci 400 Dialyzer
other name: medium cut-off dialysis membrane
intervention type: Device
intervention name: Elisio-17H dialyzer
description: 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.
arm group label: Elisio-17H
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
url: https://cjasn.asnjournals.org/content/15/9/1310
description: Related Info
citation: Weiner DE, Falzon L, Skoufos L, Bernardo A, Beck W, Xiao M, Tran H. Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1310-1319. doi: 10.2215/CJN.01210120. Epub 2020 Aug 25.
PMID: 32843372
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 