<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/NCT02198495</url>
  </required_header>
  <id_info>
    <org_study_id>COPEFER</org_study_id>
    <nct_id>NCT02198495</nct_id>
  </id_info>
  <brief_title>Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients</brief_title>
  <acronym>COPEFER</acronym>
  <official_title>Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron&#xD;
      supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with&#xD;
      or without additional use of erythropoiesis-stimulating agents (ESA).&#xD;
&#xD;
      The investigators aim to compare two different intravenous iron preparations, ferric&#xD;
      carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary&#xD;
      objective is to assess whether both agents are equally effective to maintain a target&#xD;
      haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin,&#xD;
      transferrin saturation, and how much ESA therapy is administered.&#xD;
&#xD;
      Patients will be randomly assigned to either treatment group and followed in parallel over an&#xD;
      active study period of 40 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum hemoglobin level (g/dl)</measure>
    <time_frame>40 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum ferritin level (µg/l)</measure>
    <time_frame>Week 0, 10, 20, 30, 40</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum transferrin level (mg/dl)</measure>
    <time_frame>Week 0, 10, 20, 30, 40</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of transferrin saturation (TSAT) (%)</measure>
    <time_frame>Week 0, 10, 20, 30, 40</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESA consumption in I.E./week or µg/week as appropriate</measure>
    <time_frame>Week 0, 10, 20, 30, 40</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Anemia of Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iron sucrose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Supplementation of ferric carboxymaltose</intervention_name>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Supplementation of iron sucrose</intervention_name>
    <arm_group_label>Iron sucrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Male and female patients aged ≥ 18&#xD;
&#xD;
          -  Patients with anemia and end stage kidney disease on dialysis&#xD;
&#xD;
          -  Hemoglobin ≥ 8,5g/dl&#xD;
&#xD;
          -  Ferritin &lt; 1000mg/dl&#xD;
&#xD;
          -  TSAT &lt; 50%&#xD;
&#xD;
          -  CRP &lt; 5mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin &lt; 8,5g/dl&#xD;
&#xD;
          -  Pregnancy or Nursing&#xD;
&#xD;
          -  Known allergic reaction to i.v. iron supplementation or to ingredients of&#xD;
             Investigational Medicinal Product (IMP)&#xD;
&#xD;
          -  Chronic infections (HIV, Hep B, Hep C)&#xD;
&#xD;
          -  Acute infections (CRP&gt;5mg/dl; Antibiotic therapy except for prophylactic use)&#xD;
&#xD;
          -  Malignant tumor disease&#xD;
&#xD;
          -  Oral iron supplementation at study inclusion&#xD;
&#xD;
          -  Participation in a different study at the same time&#xD;
&#xD;
          -  Active bleeding issues&#xD;
&#xD;
          -  Surgical intervention within the last 4 weeks before study inclusion&#xD;
&#xD;
          -  Mental diseases&#xD;
&#xD;
          -  Bronchial asthma&#xD;
&#xD;
          -  Atopic allergy&#xD;
&#xD;
          -  Eczema&#xD;
&#xD;
          -  Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study&#xD;
             inclusion&#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>Gere Sunder-Plassmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna, Division of Nephrology and Dialysis</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wiener Dialysezentrum GmbH</name>
      <address>
        <city>Vienna</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Gere Sunder-Plassmann</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferric Oxide, Saccharated</mesh_term>
  </intervention_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/NCT02198495
org study id: COPEFER
nct id: NCT02198495
lead sponsor: 
has dmc: No
Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron
      supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with
      or without additional use of erythropoiesis-stimulating agents (ESA).

      The investigators aim to compare two different intravenous iron preparations, ferric
      carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary
      objective is to assess whether both agents are equally effective to maintain a target
      haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin,
      transferrin saturation, and how much ESA therapy is administered.

      Patients will be randomly assigned to either treatment group and followed in parallel over an
      active study period of 40 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum hemoglobin level (g/dl)
time frame: 40 weeks
measure: Serum ferritin level (µg/l)
time frame: Week 0, 10, 20, 30, 40
measure: Serum transferrin level (mg/dl)
time frame: Week 0, 10, 20, 30, 40
measure: Serum level of transferrin saturation (TSAT) (%)
time frame: Week 0, 10, 20, 30, 40
measure: ESA consumption in I.E./week or µg/week as appropriate
time frame: Week 0, 10, 20, 30, 40
arm group label: Ferric carboxymaltose
arm group type: Active Comparator
description: Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
arm group label: Iron sucrose
arm group type: Active Comparator
description: Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38
intervention type: Drug
intervention name: Supplementation of ferric carboxymaltose
arm group label: Ferric carboxymaltose
intervention type: Drug
intervention name: Supplementation of iron sucrose
arm group label: Iron sucrose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gere Sunder-Plassmann, MD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gere Sunder-Plassmann
investigator title: Prof. Dr.
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Ferric Oxide, Saccharated