<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/NCT04487301</url>
  </required_header>
  <id_info>
    <org_study_id>SNFCT2020-07</org_study_id>
    <nct_id>NCT04487301</nct_id>
  </id_info>
  <brief_title>A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease</brief_title>
  <official_title>A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanifit Therapeutics S. A.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanifit Therapeutics S. A.</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>
      A cross-sectional, non-interventional study to assess walking performance, vascular function,&#xD;
      and lower limb calcification in subjects with peripheral artery disease and end-stage kidney&#xD;
      disease (PAD-ESKD) receiving hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Actual">June 12, 2021</completion_date>
  <primary_completion_date type="Actual">June 12, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.</time_frame>
    <description>Walking distance in meters completed over a duration of 6 minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity Patterns</measure>
    <time_frame>Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.</time_frame>
    <description>Actigraphy measurements as 24 hour intervals of motion using an accelerometer device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ankle Brachial Index</measure>
    <time_frame>Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks</time_frame>
    <description>Compares blood pressure in upper extremities and lower extremities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toe Brachial Index</measure>
    <time_frame>Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks</time_frame>
    <description>Compares blood pressure in upper extremities and lower extremities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>San Diego Claudication Questionnaire</measure>
    <time_frame>Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.</time_frame>
    <description>Will categorize the subject's perception of the leg symptoms associated with PAD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Walking Impairment Questionnaire</measure>
    <time_frame>Administered once during Week 1 during subject's participation of up to 4 weeks.</time_frame>
    <description>Will evaluate the subjects personal perception of walking ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PAD Quality of Life</measure>
    <time_frame>Administered once during Week 1 during subject's participation of up to 4 weeks.</time_frame>
    <description>Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ-SD-SL Health Questionnaire</measure>
    <time_frame>Administered once during Week 1 during subject's participation of up to 4 weeks</time_frame>
    <description>Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Wave Velocity - Sub-Study</measure>
    <time_frame>Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.</time_frame>
    <description>Measures arterial stiffness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow-Mediated Dilation - Sub-Study</measure>
    <time_frame>Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.</time_frame>
    <description>Measures the ability of blood vessels to dilate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nitroglycerin-Medicated Dilation - Sub-Study</measure>
    <time_frame>Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.</time_frame>
    <description>Measures the ability of blood vessels to dilate after administration of nitroglycerin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower limb calcification measurements</measure>
    <time_frame>Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.</time_frame>
    <description>A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.</description>
  </primary_outcome>
  <enrollment type="Actual">36</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>End Stage Renal Disease on Dialysis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample of PAD-ESKD subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥55 years of age or ≥45 years of age with diabetes&#xD;
&#xD;
          -  Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening&#xD;
&#xD;
          -  Resting ABI &lt;0.90 in either leg OR Resting TBI &lt;0.70 in either leg&#xD;
&#xD;
          -  Symptomatic as characterized by a limitation in exercise performance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Above-ankle amputation&#xD;
&#xD;
          -  Chronic limb-threatening ischemia (Rutherford 4-6)&#xD;
&#xD;
          -  Non-ambulatory status&#xD;
&#xD;
          -  A condition other than PAD that limits ability to walk&#xD;
&#xD;
          -  Open or endovascular revascularization within 3 months prior to baseline.&#xD;
&#xD;
          -  Illnesses, conditions, or planned surgeries within the study period that will&#xD;
             interfere with the interpretation of the study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alex Gold, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sanifit Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valley Renal Medical Group</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Medical Research</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Louis Kidney Care</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney &amp; Hypertension Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Medical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PAD</keyword>
  <keyword>Peripheral Artery Disease</keyword>
  <keyword>End Stage Kidney Disease</keyword>
  <keyword>End Stage Renal Disease</keyword>
  <keyword>Dialysis</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>
    <mesh_term>Peripheral Arterial Disease</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/NCT04487301
org study id: SNFCT2020-07
nct id: NCT04487301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A cross-sectional, non-interventional study to assess walking performance, vascular function,
      and lower limb calcification in subjects with peripheral artery disease and end-stage kidney
      disease (PAD-ESKD) receiving hemodialysis.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Six Minute Walk Test
time frame: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.
description: Walking distance in meters completed over a duration of 6 minutes
measure: Activity Patterns
time frame: Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.
description: Actigraphy measurements as 24 hour intervals of motion using an accelerometer device
measure: Ankle Brachial Index
time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
description: Compares blood pressure in upper extremities and lower extremities
measure: Toe Brachial Index
time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
description: Compares blood pressure in upper extremities and lower extremities
measure: San Diego Claudication Questionnaire
time frame: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
description: Will categorize the subject's perception of the leg symptoms associated with PAD
measure: Walking Impairment Questionnaire
time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
description: Will evaluate the subjects personal perception of walking ability.
measure: PAD Quality of Life
time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
description: Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.
measure: EQ-SD-SL Health Questionnaire
time frame: Administered once during Week 1 during subject's participation of up to 4 weeks
description: Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
measure: Pulse Wave Velocity - Sub-Study
time frame: Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.
description: Measures arterial stiffness
measure: Flow-Mediated Dilation - Sub-Study
time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
description: Measures the ability of blood vessels to dilate
measure: Nitroglycerin-Medicated Dilation - Sub-Study
time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
description: Measures the ability of blood vessels to dilate after administration of nitroglycerin
measure: Lower limb calcification measurements
time frame: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.
description: A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Alex Gold, MD
role: Study Director
affiliation: Sanifit Therapeutics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Peripheral Arterial Disease