<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/NCT03798860</url>
  </required_header>
  <id_info>
    <org_study_id>DSA-2018</org_study_id>
    <nct_id>NCT03798860</nct_id>
  </id_info>
  <brief_title>Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation</brief_title>
  <official_title>Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover Medical School</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>
      Single-arm, prospective observational study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study to monitor the treatment of donor-specific antibodies in lung&#xD;
      transplant recipients with detection of donor-specific antibodies. All consented subjects&#xD;
      will be approached for participation. The study will evaluate the effectiveness of the&#xD;
      treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment&#xD;
      with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Donor-specific Antibodies Clearance</measure>
    <time_frame>6, 12, 18, 24 months</time_frame>
    <description>The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graft survival</measure>
    <time_frame>1, 3, 5 years</time_frame>
    <description>Graft survival is defined as freedom from mortality and re-transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)</measure>
    <time_frame>1, 3, 5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Lung Transplantation</condition>
  <condition>Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients after lung transplantation with detection of donor-specific antibodies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients after lung transplantation with detection of donor-specific antibodies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabio Ius, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fabio Ius, Dr.</last_name>
    <phone>+49 511-532-2125</phone>
    <email>Ius.Fabio@mh-hannover.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Susanne Freyt</last_name>
    <phone>+49 511-532-3450</phone>
    <email>freyt.susanne@mh-hannover.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susanne Freyt</last_name>
      <phone>+49 511-532-3450</phone>
      <email>freyt.susanne@mh-hannover.de</email>
    </contact>
    <investigator>
      <last_name>Fabio Ius, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03798860
org study id: DSA-2018
nct id: NCT03798860
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Single-arm, prospective observational study
This is an observational study to monitor the treatment of donor-specific antibodies in lung
      transplant recipients with detection of donor-specific antibodies. All consented subjects
      will be approached for participation. The study will evaluate the effectiveness of the
      treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment
      with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.
observational model: Cohort
time perspective: Prospective
measure: Donor-specific Antibodies Clearance
time frame: 6, 12, 18, 24 months
description: The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.
measure: Graft survival
time frame: 1, 3, 5 years
description: Graft survival is defined as freedom from mortality and re-transplantation
measure: Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
time frame: 1, 3, 5 years
intervention type: Diagnostic Test
intervention name: blood samples
description: For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fabio Ius, Dr.
role: Principal Investigator
affiliation: Hannover Medical School
last name: Fabio Ius, Dr.
phone: +49 511-532-2125
email: Ius.Fabio@mh-hannover.de
last name: Susanne Freyt
phone: +49 511-532-3450
email: freyt.susanne@mh-hannover.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor