<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/NCT03229954</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0149</org_study_id>
    <nct_id>NCT03229954</nct_id>
  </id_info>
  <brief_title>Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial</brief_title>
  <official_title>Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      Iron deficiency anemia is a common complication in patients who underwent gastrectomy and&#xD;
      leads to a deterioration in patient's quality of life. Therefore iron supplementation is one&#xD;
      of the important treatments in postgastrectomy patients.&#xD;
&#xD;
      Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients&#xD;
      has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron&#xD;
      supplementation has been emerged as another treatment option, but there are only a few&#xD;
      studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron&#xD;
      in patients underwent gastrectomy.&#xD;
&#xD;
      Therefore, this study aims to evaluate the iron supplementation method as intravenous&#xD;
      injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy&#xD;
      anemia.&#xD;
&#xD;
      Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and&#xD;
      hemoglobin level lower than 11 g/dL will be included in this trial. After the registration,&#xD;
      the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n =&#xD;
      179).&#xD;
&#xD;
      Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in&#xD;
      intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral&#xD;
      iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of&#xD;
      life score at baseline and weeks 12 period will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 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>Change from Baseline Hemoglobin at 2,4,8 and 12 weeks</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum iron</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum ferritin</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum transferrin</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transferrin saturation</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL (quality of life) of the patients</measure>
    <time_frame>at Baseline and weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">358</enrollment>
  <condition>Post Gastrectomy Anemia</condition>
  <arm_group>
    <arm_group_label>IV iron (Monofer) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral iron group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>iron isomaltoside (Monofer) intravenous infusion</intervention_name>
    <description>The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (&lt; 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg.&#xD;
If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety.</description>
    <arm_group_label>IV iron (Monofer) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous sulfate(Feroba-YOU) per oral</intervention_name>
    <description>160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.</description>
    <arm_group_label>Oral iron group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥20 years of age&#xD;
&#xD;
          -  Underwent gastrectomy for stage I or II of primary gastric adenocarcinoma&#xD;
&#xD;
          -  Hb ≤11.0 g/dL at least one year after surgery&#xD;
&#xD;
          -  Willingness to participate after signing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Calculated dosage using the Ganzoni formula &gt;1,500 mg&#xD;
&#xD;
          -  Any medical condition may have caused the patient to be unsuitable for the completion&#xD;
             of the study or placed the patient at potential risk from being in the study&#xD;
&#xD;
          -  Underwent chemotherapy or on chemotherapy&#xD;
&#xD;
          -  Drug hypersensitivity to iron isomaltoside&#xD;
&#xD;
          -  Active acute or chronic infections&#xD;
&#xD;
          -  Known intolerance to oral iron treatment&#xD;
&#xD;
          -  History of anemia due to extensive bleeding or causes other than iron deficiency&#xD;
&#xD;
          -  Untreated vitamin B12 or folate deficiency&#xD;
&#xD;
          -  Blood transfusion, Erythropoiesis stimulating agents(ESA), oral iron or intravenous&#xD;
             iron treatment within 4 weeks prior to screening&#xD;
&#xD;
          -  History of bone marrow suppression treatment, active Hepatitis B or C, HIV or&#xD;
             hematologic disorder other than iron deficiency&#xD;
&#xD;
          -  Iron overload, hematochromatosis or hemosiderosis&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Creatinine clearance rate using Cockcroft-Gault formula &lt;30 mL/min&#xD;
&#xD;
          -  Participation in any other clinical study within one month prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Surgery, Yonsei University College of Medicine, Seoul, Korea</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</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>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron isomaltoside 1000</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/NCT03229954
org study id: 4-2017-0149
nct id: NCT03229954
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iron deficiency anemia is a common complication in patients who underwent gastrectomy and
      leads to a deterioration in patient's quality of life. Therefore iron supplementation is one
      of the important treatments in postgastrectomy patients.

      Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients
      has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron
      supplementation has been emerged as another treatment option, but there are only a few
      studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron
      in patients underwent gastrectomy.

      Therefore, this study aims to evaluate the iron supplementation method as intravenous
      injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy
      anemia.

      Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and
      hemoglobin level lower than 11 g/dL will be included in this trial. After the registration,
      the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n =
      179).

      Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in
      intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral
      iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of
      life score at baseline and weeks 12 period will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Hemoglobin at 2,4,8 and 12 weeks
time frame: at Baseline and weeks 2, 4, 8, and 12
measure: serum iron
time frame: at Baseline and weeks 2, 4, 8, and 12
measure: serum ferritin
time frame: at Baseline and weeks 2, 4, 8, and 12
measure: serum transferrin
time frame: at Baseline and weeks 2, 4, 8, and 12
measure: transferrin saturation
time frame: at Baseline and weeks 2, 4, 8, and 12
measure: QOL (quality of life) of the patients
time frame: at Baseline and weeks 2, 4, 8, and 12
arm group label: IV iron (Monofer) group
arm group type: Experimental
description: Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula.
arm group label: Oral iron group
arm group type: Active Comparator
description: Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral.
intervention type: Drug
intervention name: iron isomaltoside (Monofer) intravenous infusion
description: The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (< 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg.
If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety.
arm group label: IV iron (Monofer) group
intervention type: Drug
intervention name: Ferrous sulfate(Feroba-YOU) per oral
description: 160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.
arm group label: Oral iron group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Anemia
mesh term: Iron isomaltoside 1000