<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/NCT03795038</url>
  </required_header>
  <id_info>
    <org_study_id>TA-DMD-01-D</org_study_id>
    <nct_id>NCT03795038</nct_id>
  </id_info>
  <brief_title>Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI</brief_title>
  <acronym>DIAMOND-2018</acronym>
  <official_title>Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI: Cross-over Study in Patients With Cardiovascular Disease and Severe Dyslipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Medical Care Deutschland GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Medical Care Deutschland GmbH</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>
      The clinical Investigation will be performed to compare the safety and effectiveness of the&#xD;
      CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI&#xD;
      for optimizing the individual therapy of patients with severe dyslipidemia using established&#xD;
      and novel efficacy parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of the safety and effectiveness of the CE certified and established lipoprotein&#xD;
      apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of&#xD;
      patients with severe dyslipidemia using established and novel efficacy parameters.&#xD;
&#xD;
      The primary objective is to compare the whole blood lipoprotein apheresis system DALI with&#xD;
      the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in&#xD;
      removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and&#xD;
      lipoprotein (a) (Lp(a)).&#xD;
&#xD;
      The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with&#xD;
      the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in&#xD;
      removing other novel efficacy parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Actual">May 25, 2021</completion_date>
  <primary_completion_date type="Actual">May 25, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Prospective, multicentric, open, interventional, cross-over with randomization</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Removal rate of total cholesterol</measure>
    <time_frame>every week for 6 weeks or biweekly for 12 weeks</time_frame>
    <description>Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Removal rate of low density lipoprotein cholesterol (LDL-C)</measure>
    <time_frame>every week for 6 weeks or biweekly for 12 weeks</time_frame>
    <description>Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Removal rate of triglycerides</measure>
    <time_frame>every week for 6 weeks or biweekly for 12 weeks</time_frame>
    <description>Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Removal rate of lipoprotein (a) (Lp(a)).</measure>
    <time_frame>every week for 6 weeks or biweekly for 12 weeks</time_frame>
    <description>Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypercholesterolemia, Familial</condition>
  <condition>Dyslipidemias</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Lipoprotein Apheresis MONET and DALI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients routinely treated with MONET:&#xD;
The first subgroup will be treated first with the MONET adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber System.&#xD;
The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the MONET adsorber system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipoprotein Apheresis DIAMED and DALI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients routinely treated with DIAMED:&#xD;
The first subgroup will be treated first with the DIAMED adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber system.&#xD;
The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DIAMED adsorber System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipoprotein Apheresis MONET and DALI</intervention_name>
    <description>Three apheresis treatments assigned to one type of apheresis system of MONETand DALI</description>
    <arm_group_label>Lipoprotein Apheresis MONET and DALI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipoprotein Apheresis DIAMED and DALI</intervention_name>
    <description>Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI</description>
    <arm_group_label>Lipoprotein Apheresis DIAMED and DALI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent signed and dated by study patient and investigator/authorised&#xD;
             physician&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Ability to understand the nature and requirements of the study&#xD;
&#xD;
        Study-specific inclusion criteria:&#xD;
&#xD;
          -  Patients with indication for lipoprotein apheresis confirmed by a local apheresis&#xD;
             expert commission according to the German guidelines [1] and with routine lipoprotein&#xD;
             apheresis treatments for at least 3 months. Patients with weekly treatments have not&#xD;
             missed more than 3 treatment sessions within the 3 months prior inclusion to the&#xD;
             study. Patients with biweekly treatment sessions have not missed more than 1 treatment&#xD;
             session within the 3 months prior inclusion to the study&#xD;
&#xD;
          -  Patients with regular weekly or biweekly lipoprotein apheresis treatments with either&#xD;
             MONET or DIAMED lipoprotein apheresis systems for at least 4 weeks (weekly treatments)&#xD;
             or 8 weeks (biweekly treatments) with the same system&#xD;
&#xD;
          -  With adequate venous access&#xD;
&#xD;
          -  With systolic blood pressure &gt; 100 mmHg&#xD;
&#xD;
          -  With stable hematocrit &gt;35 %&#xD;
&#xD;
          -  With stable anticoagulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition which could interfere with the patient's ability to comply with the&#xD;
             study&#xD;
&#xD;
          -  Pregnancy or lactation period (pregnancy test will be conducted with female patients&#xD;
             aged 55 years)&#xD;
&#xD;
          -  Participation in an interventional clinical study during the preceding 30 days or in&#xD;
             the same study&#xD;
&#xD;
        Study-specific exclusion criteria:&#xD;
&#xD;
          -  Occurrence or clinical relevant deterioration of acute myocardial infarction, unstable&#xD;
             angina pectoris, severe hemo-dynamic relevant arrhythmia within 3 months prior&#xD;
             inclusion to the study&#xD;
&#xD;
          -  Bypass surgery, vascular diseases, active infection (this means chronic infectious&#xD;
             diseases (e.g. chronic hepatitis) and acute infections with a core body temperature ≥&#xD;
             38.0 °C) or unstable circulation (see exclusion criteria no. 7) within the last 3&#xD;
             months&#xD;
&#xD;
          -  Uncontrolled high or low blood pressure defined as systolic blood pressure &gt;180&#xD;
             mmHg/&lt;100 mmHg and/or diastolic blood pressure &gt;115 mmHg (after three times measuring)&#xD;
&#xD;
          -  Changes in lipid lowering medication within the last 2 weeks&#xD;
&#xD;
          -  Intake of Angiotensin Converting Enzyme (ACE) inhibitor medication within a time&#xD;
             interval of five times the terminal half-life of the ACE inhibitor before study start&#xD;
             and during the study&#xD;
&#xD;
          -  History of allergic reactions to anticoagulation&#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>Heinrich Prophet, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nephrocare Rostock GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nephrocare Rostock GmbH</name>
      <address>
        <city>Rostock</city>
        <state>Mecklenburg-Vorpommern</state>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lipoprotein apheresis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Dyslipidemias</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/NCT03795038
org study id: TA-DMD-01-D
nct id: NCT03795038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The clinical Investigation will be performed to compare the safety and effectiveness of the
      CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI
      for optimizing the individual therapy of patients with severe dyslipidemia using established
      and novel efficacy parameters.
Comparison of the safety and effectiveness of the CE certified and established lipoprotein
      apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of
      patients with severe dyslipidemia using established and novel efficacy parameters.

      The primary objective is to compare the whole blood lipoprotein apheresis system DALI with
      the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in
      removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and
      lipoprotein (a) (Lp(a)).

      The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with
      the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in
      removing other novel efficacy parameters.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Prospective, multicentric, open, interventional, cross-over with randomization
primary purpose: Treatment
masking: None (Open Label)
measure: Removal rate of total cholesterol
time frame: every week for 6 weeks or biweekly for 12 weeks
description: Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
measure: Removal rate of low density lipoprotein cholesterol (LDL-C)
time frame: every week for 6 weeks or biweekly for 12 weeks
description: Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
measure: Removal rate of triglycerides
time frame: every week for 6 weeks or biweekly for 12 weeks
description: Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
measure: Removal rate of lipoprotein (a) (Lp(a)).
time frame: every week for 6 weeks or biweekly for 12 weeks
description: Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
arm group label: Lipoprotein Apheresis MONET and DALI
arm group type: Other
description: Patients routinely treated with MONET:
The first subgroup will be treated first with the MONET adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber System.
The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the MONET adsorber system
arm group label: Lipoprotein Apheresis DIAMED and DALI
arm group type: Other
description: Patients routinely treated with DIAMED:
The first subgroup will be treated first with the DIAMED adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber system.
The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DIAMED adsorber System.
intervention type: Device
intervention name: Lipoprotein Apheresis MONET and DALI
description: Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
arm group label: Lipoprotein Apheresis MONET and DALI
intervention type: Device
intervention name: Lipoprotein Apheresis DIAMED and DALI
description: Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
arm group label: Lipoprotein Apheresis DIAMED and DALI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heinrich Prophet, Dr. med.
role: Principal Investigator
affiliation: Nephrocare Rostock GmbH
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Hyperlipoproteinemia Type II
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias