<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/NCT03787719</url>
  </required_header>
  <id_info>
    <org_study_id>6021932</org_study_id>
    <nct_id>NCT03787719</nct_id>
  </id_info>
  <brief_title>Dialysis-Less Frequently In The Elderly</brief_title>
  <acronym>D-LITE</acronym>
  <official_title>Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thrice-weekly dialysis is the accepted standard of care for hemodialysis (HD) patients.&#xD;
      Observational studies suggest that elderly HD patients do as well and have better quality of&#xD;
      life with less dialysis (ie twice-weekly). We propose a single-center pilot study of 40&#xD;
      patients to determine the feasibility of a large randomized controlled trial (RCT) designed&#xD;
      to determine the impact of HD frequency on well-being in new HD patients above the age of 70.&#xD;
      The primary outcomes will be metrics of feasibility and safety. We hypothesize that an&#xD;
      adequately powered RCT that will determine whether elderly patients who dialyze twice weekly&#xD;
      have improved well-being compared to thrice-weekly is feasible&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-center pilot study of 40 patients is designed to determine the feasibility and&#xD;
      safety of a large randomized controlled trial examining the impact of hemodialysis frequency&#xD;
      on well-being, a patient reported outcome, in incident patients with end stage kidney disease&#xD;
      who are above the age of 70. Subjects meeting inclusion criteria will be enrolled into the&#xD;
      trial if they are still alive 7 weeks post HD initiation. Once enrolled, subjects will&#xD;
      continue thrice weekly HD, have weekly potassium measured, have intra-dialytic weight gain&#xD;
      and dry weight assessed weekly and have any extra or missed HD sessions and death recorded.&#xD;
      Six weeks post enrollment, subjects meeting inclusion for randomization (potassium within&#xD;
      normal range on K2,3 or 4 bath and mean inter-dialytic weight gain of less than 2 L and&#xD;
      within 1.0 kg of their prescribed dry weight on weeks 5 and 6) will have residual GFR&#xD;
      measured by iohexol clearance and by the average of 48 hour urea and creatinine clearance.&#xD;
      Randomization will be 1:1 using permuted blocks of undisclosed varying size and stratified by&#xD;
      residual kidney function (RKF) (&lt;5 ml/min, 5-10 ml/min and &gt;10 ml/min) measured by the&#xD;
      average of 48 hour urea and creatinine clearance. Throughout the remaining 9 months,&#xD;
      potassium will be measured weekly, interdialytic weight gain recorded, and missed or extra HD&#xD;
      sessions and death will be recorded. Every 6 weeks, ESAs-r and every 3 months the SF-36 will&#xD;
      be completed. The primary outcome for this single-center pilot study will be metrics of&#xD;
      feasibility and safety. Feasibility will be assessed by rate of enrollment into the trial and&#xD;
      rate of subsequent randomization to a treatment arm, adherence to protocol and loss to trial&#xD;
      completion. Safety will be assessed by measures of serum potassium and achievement of target&#xD;
      weight. We hypothesize that an adequately powered RCT (The D-LITE Main Trial) that will&#xD;
      determine whether elderly patients who dialyze twice weekly have better self-reported&#xD;
      well-being compared to thrice weekly will be feasible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 27, 2018</start_date>
  <completion_date type="Anticipated">September 11, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 11, 2023</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>
    <intervention_model_description>Single center pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>1 year</time_frame>
    <description>Successful recruitment will be defined as &gt;3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent of prescribed treatments completed by patient</measure>
    <time_frame>1 year</time_frame>
    <description>Successful adherence will be defined as =&gt; 90% of intervention being adhered to.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Loss to trial completion</measure>
    <time_frame>1 year</time_frame>
    <description>Successful loss to trial completion will be defined as = &gt;50% of randomized patients completing the 12 month trial. Based on our data, the anticipated reasons for loss to trial completion will be death and moving away from the study center.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of weekly potassium values falling within normal range.</measure>
    <time_frame>1 year</time_frame>
    <description>Potassium will be measured every week for the duration of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight</measure>
    <time_frame>1 year</time_frame>
    <description>Prescribed and acheived post HD weight will be recorded weekly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)</measure>
    <time_frame>1 year</time_frame>
    <description>The purpose of the ESAS tool is to help with the assessment of 9 symptoms which includes: pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath and well-being.&#xD;
The ESAS-R is a semantic differential scale which asks respondents to answer a questionnaire and choose between two opposite position (e.g., &quot;No Pain&quot; or &quot;Worst Possible Pain&quot;, &quot;No Tiredness&quot; or &quot;Worst Possible Tiredness&quot;, etc). The patient will rate the severity of each symptom from 0 to 10. The lower the value the better the outcome.&#xD;
This study will measure the change in ESAS-r symptoms over time. The ESAS-r is always done on the ESAS-r numerical scale and the results later transferred to the ESAS-r Graph.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Dialysis</condition>
  <condition>End Stage Renal Disease</condition>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Twice per week dialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thrice per week dialysis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Twice per week dialysis</intervention_name>
    <description>Twice-weekly 4 hour dialysis treatment</description>
    <arm_group_label>Twice per week dialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than equal 70 years old, planned ongoing in-center HD treatment&#xD;
&#xD;
          -  Incident HD patient and still alive 7 weeks post HD initiation&#xD;
&#xD;
          -  Patient or substitute decision maker provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant barriers to ascertainment of the patient-reported experience measures&#xD;
&#xD;
          -  Patient currently admitted to hospital without Alternate Level of Care designation&#xD;
&#xD;
          -  Patient non-adherent to dialysis prescription&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christine White, MD</last_name>
    <phone>613-533-3134</phone>
    <email>cw38@queensu.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrew L Nguyen, MSc</last_name>
    <phone>613-533-6000</phone>
    <phone_ext>74500</phone_ext>
    <email>aln4@queensu.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre (KHSC)</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christine White, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hasitha Welihinda, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Christine White</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Twice weekly dialysis</keyword>
  <keyword>Thrice weekly dialysis</keyword>
  <keyword>End Stage Renal Disease</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03787719
org study id: 6021932
nct id: NCT03787719
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Thrice-weekly dialysis is the accepted standard of care for hemodialysis (HD) patients.
      Observational studies suggest that elderly HD patients do as well and have better quality of
      life with less dialysis (ie twice-weekly). We propose a single-center pilot study of 40
      patients to determine the feasibility of a large randomized controlled trial (RCT) designed
      to determine the impact of HD frequency on well-being in new HD patients above the age of 70.
      The primary outcomes will be metrics of feasibility and safety. We hypothesize that an
      adequately powered RCT that will determine whether elderly patients who dialyze twice weekly
      have improved well-being compared to thrice-weekly is feasible
This single-center pilot study of 40 patients is designed to determine the feasibility and
      safety of a large randomized controlled trial examining the impact of hemodialysis frequency
      on well-being, a patient reported outcome, in incident patients with end stage kidney disease
      who are above the age of 70. Subjects meeting inclusion criteria will be enrolled into the
      trial if they are still alive 7 weeks post HD initiation. Once enrolled, subjects will
      continue thrice weekly HD, have weekly potassium measured, have intra-dialytic weight gain
      and dry weight assessed weekly and have any extra or missed HD sessions and death recorded.
      Six weeks post enrollment, subjects meeting inclusion for randomization (potassium within
      normal range on K2,3 or 4 bath and mean inter-dialytic weight gain of less than 2 L and
      within 1.0 kg of their prescribed dry weight on weeks 5 and 6) will have residual GFR
      measured by iohexol clearance and by the average of 48 hour urea and creatinine clearance.
      Randomization will be 1:1 using permuted blocks of undisclosed varying size and stratified by
      residual kidney function (RKF) (<5 ml/min, 5-10 ml/min and >10 ml/min) measured by the
      average of 48 hour urea and creatinine clearance. Throughout the remaining 9 months,
      potassium will be measured weekly, interdialytic weight gain recorded, and missed or extra HD
      sessions and death will be recorded. Every 6 weeks, ESAs-r and every 3 months the SF-36 will
      be completed. The primary outcome for this single-center pilot study will be metrics of
      feasibility and safety. Feasibility will be assessed by rate of enrollment into the trial and
      rate of subsequent randomization to a treatment arm, adherence to protocol and loss to trial
      completion. Safety will be assessed by measures of serum potassium and achievement of target
      weight. We hypothesize that an adequately powered RCT (The D-LITE Main Trial) that will
      determine whether elderly patients who dialyze twice weekly have better self-reported
      well-being compared to thrice weekly will be feasible.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single center pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment
time frame: 1 year
description: Successful recruitment will be defined as >3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.
measure: percent of prescribed treatments completed by patient
time frame: 1 year
description: Successful adherence will be defined as => 90% of intervention being adhered to.
measure: Loss to trial completion
time frame: 1 year
description: Successful loss to trial completion will be defined as = >50% of randomized patients completing the 12 month trial. Based on our data, the anticipated reasons for loss to trial completion will be death and moving away from the study center.
measure: Percent of weekly potassium values falling within normal range.
time frame: 1 year
description: Potassium will be measured every week for the duration of the study.
measure: Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight
time frame: 1 year
description: Prescribed and acheived post HD weight will be recorded weekly.
measure: Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)
time frame: 1 year
description: The purpose of the ESAS tool is to help with the assessment of 9 symptoms which includes: pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath and well-being.
The ESAS-R is a semantic differential scale which asks respondents to answer a questionnaire and choose between two opposite position (e.g., "No Pain" or "Worst Possible Pain", "No Tiredness" or "Worst Possible Tiredness", etc). The patient will rate the severity of each symptom from 0 to 10. The lower the value the better the outcome.
This study will measure the change in ESAS-r symptoms over time. The ESAS-r is always done on the ESAS-r numerical scale and the results later transferred to the ESAS-r Graph.
arm group label: Twice per week dialysis
arm group type: Experimental
description: Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).
arm group label: Thrice per week dialysis
arm group type: No Intervention
description: Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)
intervention type: Other
intervention name: Twice per week dialysis
description: Twice-weekly 4 hour dialysis treatment
arm group label: Twice per week dialysis
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Christine White, MD
phone: 613-533-3134
email: cw38@queensu.ca
last name: Andrew L Nguyen, MSc
phone: 613-533-6000
phone ext: 74500
email: aln4@queensu.ca
facility: 
status: Recruiting
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Christine White
investigator title: Associate Professor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic