<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/NCT03270371</url>
  </required_header>
  <id_info>
    <org_study_id>MCO-CS-559/16S</org_study_id>
    <nct_id>NCT03270371</nct_id>
  </id_info>
  <brief_title>Modulation of Inflammation by Medium Cut Off Membranes</brief_title>
  <acronym>MCO-IF</acronym>
  <official_title>Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      This study examines whether medium-cut off dialysis results in improved blood purification of&#xD;
      large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments&#xD;
      with conventional high-flux dialyzers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular events and sepsis remain the leading causes of mortality in patients on&#xD;
      maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the&#xD;
      prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in&#xD;
      hemodialysis patients remain elusive, but chronic inflammation seems to play a central role&#xD;
      in the pathogenesis of cardiovascular disease in HD patients.&#xD;
&#xD;
      Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle&#xD;
      molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators&#xD;
      as the non-protein bound inflammatory mediators lie within the cut off range of this&#xD;
      membrane. The investigators designed this study to get information on the changes in the&#xD;
      inflammatory milieu in dialysis patients when using medium-cut off membranes which are know&#xD;
      to significantly reduce cytokines compared to standard high-flux dialyzers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in inflammation</measure>
    <time_frame>240 days (cross-over design, multiple measurements)</time_frame>
    <description>change of inflammatory score (inflammatory score is derived from multiple biomarkers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in calcification status</measure>
    <time_frame>240 days (cross-over design, multiple measurements)</time_frame>
    <description>calcification score derived from several pro- and anticalcifying biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in calcification propensity</measure>
    <time_frame>240 days (cross-over design, multiple measurements)</time_frame>
    <description>this values measures the resistence of serum to a calcification stimulus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>MCO Dialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Theranova Dialyzer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard High Flux Dialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard High Flux Dialyzer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medium cut off dialysis</intervention_name>
    <description>Hemodialysis</description>
    <arm_group_label>MCO Dialysis</arm_group_label>
    <other_name>Theranova Dialyzer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard High Flux Dialyzer</intervention_name>
    <description>Hemodialysis</description>
    <arm_group_label>Standard High Flux Dialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  time since initiation of dialysis &gt; 3 months&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  time since initiation of dialysis &lt; 3 months&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  ongoing acute or chronic infection/malignoma, because this will interfere with&#xD;
             inflammatory baseline values&#xD;
&#xD;
          -  major surgery less than 2 weeks before inclusion in the study&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  mental illness&#xD;
&#xD;
          -  lack of written and informed consent&#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>Christoph Schmaderer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>attending Department of Nephrology, Klinikum rechts der Isar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christoph Schmaderer, MD</last_name>
    <phone>0049894140</phone>
    <phone_ext>5053</phone_ext>
    <email>christoph.schmaderer@mri.tum.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Georg Lorenz, MD</last_name>
    <phone>0049894140</phone>
    <phone_ext>6704</phone_ext>
    <email>georg.lorenz@mri.tum.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of nephrology, Klinikum rechts der Isar</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Schmaderer, M.D.</last_name>
      <phone>0049-89-4140</phone>
      <phone_ext>6701</phone_ext>
      <email>christoph.schmaderer@lrz.tum.de</email>
    </contact>
    <contact_backup>
      <last_name>Georg Lorenz, M.D.</last_name>
      <phone>0049-89-4140</phone>
      <phone_ext>6704</phone_ext>
      <email>georg.lorenz@googlemail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Christoph Schmaderer, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.</citation>
    <PMID>28535525</PMID>
  </reference>
  <reference>
    <citation>Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.</citation>
    <PMID>28085888</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03270371
org study id: MCO-CS-559/16S
nct id: NCT03270371
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines whether medium-cut off dialysis results in improved blood purification of
      large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments
      with conventional high-flux dialyzers.
Cardiovascular events and sepsis remain the leading causes of mortality in patients on
      maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the
      prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in
      hemodialysis patients remain elusive, but chronic inflammation seems to play a central role
      in the pathogenesis of cardiovascular disease in HD patients.

      Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle
      molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators
      as the non-protein bound inflammatory mediators lie within the cut off range of this
      membrane. The investigators designed this study to get information on the changes in the
      inflammatory milieu in dialysis patients when using medium-cut off membranes which are know
      to significantly reduce cytokines compared to standard high-flux dialyzers.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking
measure: Change in inflammation
time frame: 240 days (cross-over design, multiple measurements)
description: change of inflammatory score (inflammatory score is derived from multiple biomarkers)
measure: Change in calcification status
time frame: 240 days (cross-over design, multiple measurements)
description: calcification score derived from several pro- and anticalcifying biomarkers
measure: change in calcification propensity
time frame: 240 days (cross-over design, multiple measurements)
description: this values measures the resistence of serum to a calcification stimulus
arm group label: MCO Dialysis
arm group type: Experimental
description: Theranova Dialyzer
arm group label: Standard High Flux Dialysis
arm group type: Active Comparator
description: Standard High Flux Dialyzer
intervention type: Device
intervention name: Medium cut off dialysis
description: Hemodialysis
arm group label: MCO Dialysis
other name: Theranova Dialyzer
intervention type: Device
intervention name: Standard High Flux Dialyzer
description: Hemodialysis
arm group label: Standard High Flux Dialysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Schmaderer, MD
role: Principal Investigator
affiliation: attending Department of Nephrology, Klinikum rechts der Isar
last name: Christoph Schmaderer, MD
phone: 0049894140
phone ext: 5053
email: christoph.schmaderer@mri.tum.de
last name: Georg Lorenz, MD
phone: 0049894140
phone ext: 6704
email: georg.lorenz@mri.tum.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
citation: Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.
PMID: 28535525
citation: Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PMID: 28085888
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Cardiovascular Diseases
sharing ipd: No