<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/NCT01726868</url>
  </required_header>
  <id_info>
    <org_study_id>CCE-001</org_study_id>
    <nct_id>NCT01726868</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism</brief_title>
  <official_title>Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Japan Community Health Care Organization Sendai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Japan Community Health Care Organization Sendai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate efficacy and safety of blood purification therapy on&#xD;
      renal dysfunction by cholesterol crystal embolism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of chronic hemodialysis</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose of drugs</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of lower limb amputation</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of gangrene</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of multi organ failure</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Cholesterol Embolism</condition>
  <arm_group>
    <arm_group_label>Liposorber LA-15 System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Liposorber LA-15 System</intervention_name>
    <description>Six sessions of blood purification treatment with Liposorber LA-15 System.</description>
    <arm_group_label>Liposorber LA-15 System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who meet all of the following criteria.&#xD;
&#xD;
          -  Patients who had cardiac catheterization or vascular surgery in the last 24 weeks&#xD;
             before the time of obtaining informed consent.&#xD;
&#xD;
          -  Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or&#xD;
             renal biopsy.&#xD;
&#xD;
               1. Patients with progressive renal dysfunction in the course of weeks or months.&#xD;
&#xD;
               2. Patients with skin lesions such as livedo reticularis of lower extremities or&#xD;
                  blue toe syndrome.&#xD;
&#xD;
               3. Eosinophil count is more than 400 per microliter.&#xD;
&#xD;
          -  Patients who or patients whose legal representative understood the requirements of the&#xD;
             study and signed the informed consent forms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of the following criteria will be excluded.&#xD;
&#xD;
          -  Patients with contraindication to anticoagulant (Nafamostat Mesilate).&#xD;
&#xD;
          -  Blood purification therapy is inapplicable because of severe heart failure, acute&#xD;
             myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable&#xD;
             hypertension or hypotension.&#xD;
&#xD;
          -  Patients with body weight less than 40kg.&#xD;
&#xD;
          -  Patients with a history of allergic reaction or hypersensitivity to blood&#xD;
             purification.&#xD;
&#xD;
          -  Patients who cannot stop taking ACE inhibitors.&#xD;
&#xD;
          -  Patients with any disease in which corticosteroid, statin are contraindicated.&#xD;
&#xD;
          -  Patients participated in another clinical trial or study at the time of obtaining&#xD;
             informed consent.&#xD;
&#xD;
          -  Patients receiving chronic hemodialysis.&#xD;
&#xD;
          -  Otherwise, patients who are judged by the investigator as being unsuitable for&#xD;
             inclusion in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toshinobu Sato, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Japan Community Health Care Organization Sendai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Toshinobu Sato, MD, PhD</last_name>
    <phone>+81-22-275-3111</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Sendai Shakaihoken Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>981-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toshinobu Sato, MD, PhD</last_name>
      <phone>+81-22-275-3111</phone>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>June 30, 2016</last_update_submitted>
  <last_update_submitted_qc>June 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Japan Community Health Care Organization Sendai Hospital</investigator_affiliation>
    <investigator_full_name>TOSHINOBU SATO</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Embolism, Cholesterol</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/NCT01726868
org study id: CCE-001
nct id: NCT01726868
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate efficacy and safety of blood purification therapy on
      renal dysfunction by cholesterol crystal embolism.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of chronic hemodialysis
time frame: Six months
measure: Dose of drugs
time frame: Six months
measure: Incidence of lower limb amputation
time frame: Six months
measure: Incidence of gangrene
time frame: Six months
measure: Incidence of multi organ failure
time frame: Six months
measure: Survival rate
time frame: Six months
measure: Incidence of adverse events
time frame: Six months
arm group label: Liposorber LA-15 System
arm group type: Experimental
intervention type: Device
intervention name: Liposorber LA-15 System
description: Six sessions of blood purification treatment with Liposorber LA-15 System.
arm group label: Liposorber LA-15 System
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Toshinobu Sato, MD, PhD
role: Study Director
affiliation: Japan Community Health Care Organization Sendai Hospital
last name: Toshinobu Sato, MD, PhD
phone: +81-22-275-3111
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Japan Community Health Care Organization Sendai Hospital
investigator full name: TOSHINOBU SATO
investigator title: MD, PhD
mesh term: Embolism
mesh term: Embolism, Cholesterol