xml: <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/NCT06032208</url>
    </required_header>
    <id_info>
      <org_study_id>123850</org_study_id>
      <nct_id>NCT06032208</nct_id>
    </id_info>
    <brief_title>An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL</brief_title>
    <official_title>An Extension of an Interventional Study to Assess the Effect of Expanded Dialysis (HDx-Theranova) on Patient Reported Symptoms Using London Evaluation of Illness (LEVIL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lawson Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Baxter Healthcare Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Lawson Health Research Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Investigators know that many patients who are on dialysis suffer from burden of unwanted&#xD;
        symptoms, which can affect quality of life. The understanding and treatment of symptom burden&#xD;
        by healthcare providers is limited and should be recognized as a high priority in the care of&#xD;
        the dialysis population. In this study, the investigators will be assessing symptom burden&#xD;
        using the London Evaluation of Illness &quot;LEVIL,&quot; an application based platform where patients&#xD;
        self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks.&#xD;
        The investigators would like to compare the currently available dialyzer with a new dialyzer&#xD;
        that is capable of removing solutes of higher molecular weight that may or may not cause&#xD;
        patients to experience symptoms related to increased amounts of toxins in their blood.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Baxter Canada has an expanded hemodialysis (HDx) membrane called the &quot;Theranova&quot;, which is&#xD;
        capable of removing solutes of higher molecular weight. Although this clearly has biochemical&#xD;
        advantages it is not known at this time if the removal of larger middle molecules can have a&#xD;
        direct and immediate effect on patients reported symptoms and quality of life. In short, do&#xD;
        people actually feel better?&#xD;
  &#xD;
        Given the way many quality of life measurements fluctuate around the dialysis week, the&#xD;
        investigators propose to utilize a dynamic tool. The investigators will be assessing symptom&#xD;
        burden using the London Evaluation of Illness &quot;LEVIL&quot; an application based platform where&#xD;
        patients self-report their symptoms with at least one hemodialysis treatment. Reports are&#xD;
        generated immediately and in real-time, which cannot be accomplished with other symptom&#xD;
        management tools. This allows the investigators to track study changes and benchmark&#xD;
        observations to previously established baseline values. The investigators are excited to see&#xD;
        if there is an imminent effect on how patients feel using the Theranova dialyzer.&#xD;
  &#xD;
        The study is investigator initiated and the principal investigator has secured modest funding&#xD;
        from Baxter to allow support for the core study team and the introduction and maintenance of&#xD;
        the LEVIL evaluation platform at other centers. Baxter have also provided some dialyzer&#xD;
        support and will work with individual centers to ensure that there is no consumable increment&#xD;
        of cost associated with participation.&#xD;
  &#xD;
        The study is 28 weeks in length:&#xD;
  &#xD;
          -  LEVIL entries with at least 1 to 3 hemodialysis treatments each week for 28 weeks.&#xD;
  &#xD;
          -  Implementation of Theranova dialyzer from week 5 until the end of week 28.&#xD;
  &#xD;
          -  Creyos (cognitive testing) one time at baseline (between weeks 1 to 4) and again during&#xD;
             week 28.&#xD;
  &#xD;
          -  Sexual Desire questionnaire one time at baseline (between weeks 1 to 4) and again during&#xD;
             week 28.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Study visits take place within the patients usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 5 participants will use the Theranova dialyzer until the end of dialysis week 28. Participants will answer 9 questions at least (1-3 times weekly) - weeks 1 through 28 (entire length of study) using the LEVIL application.&#xD;
  Furthermore, participants answer a single Time-to-Recovery question between weeks 1-4 and repeated at week 28 to get more information on recovery time after dialysis in addition to completing Creyos (cognitive testing formally Cambridge Brain Sciences), as well as Sexual Desire Inventory-2 testing.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.</measure>
      <time_frame>Beginning week 1 and ending at the end of dialysis on week 28.</time_frame>
      <description>The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep. breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL, an electronic application based visual analog scale.&#xD;
  The scale indicates Very Poor on the left and Excellent to the right or Extreme on the left to No Problem on the right. Participants will use their finger and slide the scale to indicate which best describes how they feel.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.</measure>
      <time_frame>Between weeks 1 &amp; 4 and repeated during week 28</time_frame>
      <description>Cognitive Testing measured using Creyos (formally Cambridge Brain Sciences) web-based application at baseline (between weeks 1 &amp; 4) and repeated at week 28.&#xD;
  Creyos consists of tasks that are separated into domains of reasoning, short term memory, and verbal abilities:&#xD;
  1. Odd one Out (patterns), 2. Digit Span (number sequence), 3. Paired Association Task, 5. Rotations Task, 6. Monkey Ladder Task</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire</measure>
      <time_frame>Between weeks 1 &amp; 4 and repeated during week 28</time_frame>
      <description>Parameters will be measured using Sexual Desires Inventory-2 (SDI-2) an anonymous web-based platform at baseline (between weeks 1 &amp; 4) and repeated at week 28.&#xD;
  SDI-2 is a multiple choice platform where participants will privately answer questions that best describes how they feel. (eg. not at all, once a month, once every two months, once a week, twice a week, 3 to 4 times a week, once a day, more then once a day) A score will be populated within the app and the score will be recorded only.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects dialysis recovery time compared to high-flux dialysis membrane.</measure>
      <time_frame>Between weeks 1 &amp; 4 and repeated during week 28</time_frame>
      <description>Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 &amp; 4) and repeated at week 28.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>End Stage Renal Disease</condition>
    <arm_group>
      <arm_group_label>Patients receiving Hemodialysis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Theranova Dialyzer</intervention_name>
      <description>The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.</description>
      <arm_group_label>Patients receiving Hemodialysis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Conventional thrice weekly HD schedule&#xD;
  &#xD;
            -  Must be on hemodialysis for at least 3 months&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Willing and able to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active infection (may enroll once infection is cleared)&#xD;
  &#xD;
            -  Patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated&#xD;
               ultrafiltration (ISO UF) more than once in three months&#xD;
  &#xD;
            -  Visual impairment&#xD;
  &#xD;
            -  History of neurocognitive impairment&#xD;
  &#xD;
            -  History of stroke (CVA)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christopher McIntyre, MBBS DM</last_name>
      <role>Principal Investigator</role>
      <affiliation>London Heath Sciences Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christopher McIntyre, MBBS DM</last_name>
      <phone>5196858500</phone>
      <phone_ext>58502</phone_ext>
      <email>Christopher.McIntyre@lhsc.on.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jarrin Penny, PHD RN CNeph</last_name>
      <phone>519-685-8500</phone>
      <phone_ext>58765</phone_ext>
      <email>jarrin.penny@lhsc.on.ca</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
      <investigator_full_name>Chris McIntyre</investigator_full_name>
      <investigator_title>Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation</investigator_title>
    </responsible_party>
    <keyword>Hemodialysis</keyword>
    <keyword>Large middle molecules</keyword>
    <keyword>Theranova</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032208
  org study id: 123850
  nct id: NCT06032208
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigators know that many patients who are on dialysis suffer from burden of unwanted
        symptoms, which can affect quality of life. The understanding and treatment of symptom burden
        by healthcare providers is limited and should be recognized as a high priority in the care of
        the dialysis population. In this study, the investigators will be assessing symptom burden
        using the London Evaluation of Illness "LEVIL," an application based platform where patients
        self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks.
        The investigators would like to compare the currently available dialyzer with a new dialyzer
        that is capable of removing solutes of higher molecular weight that may or may not cause
        patients to experience symptoms related to increased amounts of toxins in their blood.
  Baxter Canada has an expanded hemodialysis (HDx) membrane called the "Theranova", which is
        capable of removing solutes of higher molecular weight. Although this clearly has biochemical
        advantages it is not known at this time if the removal of larger middle molecules can have a
        direct and immediate effect on patients reported symptoms and quality of life. In short, do
        people actually feel better?
  
        Given the way many quality of life measurements fluctuate around the dialysis week, the
        investigators propose to utilize a dynamic tool. The investigators will be assessing symptom
        burden using the London Evaluation of Illness "LEVIL" an application based platform where
        patients self-report their symptoms with at least one hemodialysis treatment. Reports are
        generated immediately and in real-time, which cannot be accomplished with other symptom
        management tools. This allows the investigators to track study changes and benchmark
        observations to previously established baseline values. The investigators are excited to see
        if there is an imminent effect on how patients feel using the Theranova dialyzer.
  
        The study is investigator initiated and the principal investigator has secured modest funding
        from Baxter to allow support for the core study team and the introduction and maintenance of
        the LEVIL evaluation platform at other centers. Baxter have also provided some dialyzer
        support and will work with individual centers to ensure that there is no consumable increment
        of cost associated with participation.
  
        The study is 28 weeks in length:
  
          -  LEVIL entries with at least 1 to 3 hemodialysis treatments each week for 28 weeks.
  
          -  Implementation of Theranova dialyzer from week 5 until the end of week 28.
  
          -  Creyos (cognitive testing) one time at baseline (between weeks 1 to 4) and again during
             week 28.
  
          -  Sexual Desire questionnaire one time at baseline (between weeks 1 to 4) and again during
             week 28.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Study visits take place within the patients usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 5 participants will use the Theranova dialyzer until the end of dialysis week 28. Participants will answer 9 questions at least (1-3 times weekly) - weeks 1 through 28 (entire length of study) using the LEVIL application.
  Furthermore, participants answer a single Time-to-Recovery question between weeks 1-4 and repeated at week 28 to get more information on recovery time after dialysis in addition to completing Creyos (cognitive testing formally Cambridge Brain Sciences), as well as Sexual Desire Inventory-2 testing.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.
  time frame: Beginning week 1 and ending at the end of dialysis on week 28.
  description: The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep. breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL, an electronic application based visual analog scale.
  The scale indicates Very Poor on the left and Excellent to the right or Extreme on the left to No Problem on the right. Participants will use their finger and slide the scale to indicate which best describes how they feel.
  measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.
  time frame: Between weeks 1 & 4 and repeated during week 28
  description: Cognitive Testing measured using Creyos (formally Cambridge Brain Sciences) web-based application at baseline (between weeks 1 & 4) and repeated at week 28.
  Creyos consists of tasks that are separated into domains of reasoning, short term memory, and verbal abilities:
  1. Odd one Out (patterns), 2. Digit Span (number sequence), 3. Paired Association Task, 5. Rotations Task, 6. Monkey Ladder Task
  measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire
  time frame: Between weeks 1 & 4 and repeated during week 28
  description: Parameters will be measured using Sexual Desires Inventory-2 (SDI-2) an anonymous web-based platform at baseline (between weeks 1 & 4) and repeated at week 28.
  SDI-2 is a multiple choice platform where participants will privately answer questions that best describes how they feel. (eg. not at all, once a month, once every two months, once a week, twice a week, 3 to 4 times a week, once a day, more then once a day) A score will be populated within the app and the score will be recorded only.
  measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects dialysis recovery time compared to high-flux dialysis membrane.
  time frame: Between weeks 1 & 4 and repeated during week 28
  description: Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 & 4) and repeated at week 28.
  arm group label: Patients receiving Hemodialysis
  arm group type: Experimental
  description: A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.
  intervention type: Device
  intervention name: Theranova Dialyzer
  description: The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.
  arm group label: Patients receiving Hemodialysis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christopher McIntyre, MBBS DM
  role: Principal Investigator
  affiliation: London Heath Sciences Centre
  last name: Christopher McIntyre, MBBS DM
  phone: 5196858500
  phone ext: 58502
  email: Christopher.McIntyre@lhsc.on.ca
  last name: Jarrin Penny, PHD RN CNeph
  phone: 519-685-8500
  phone ext: 58765
  email: jarrin.penny@lhsc.on.ca
  responsible party type: Principal Investigator
  investigator affiliation: Lawson Health Research Institute
  investigator full name: Chris McIntyre
  investigator title: Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation
  mesh term: Kidney Failure, Chronic