<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/NCT01725789</url>
  </required_header>
  <id_info>
    <org_study_id>NCCCTS-12-644</org_study_id>
    <nct_id>NCT01725789</nct_id>
  </id_info>
  <brief_title>Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)</brief_title>
  <official_title>A Randomized Patient -Blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject®) With Placebo in Patients With Acute Isovolemic Anemia After Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic&#xD;
      anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective&#xD;
      measures (Hb and iron parameters).&#xD;
&#xD;
      Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a&#xD;
      cut-off value for our study based on the guidelines published by American Society of Clinical&#xD;
      Oncology and the American Society of Hematology for the treatment of cancer-related anemia,&#xD;
      recommending Hb&lt;10 g/dl as a treatment threshold.&#xD;
&#xD;
      Ferinject® to be administered based on Hb and body weight per approved summary of product&#xD;
      characteristics (SmPC).&#xD;
&#xD;
      5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb&lt;10g/dl will&#xD;
      be administered Ferinject® or placebo (normal saline) based on the results of randomization.&#xD;
&#xD;
      • Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection&#xD;
      with a minimum administration time of 15minutes (for 1000mg single administration) for body&#xD;
      weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight &lt;50Kg .&#xD;
&#xD;
      Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients&#xD;
      with a body weight &lt;50kg, administration of Ferinject® should be limited to 500mg at baseline&#xD;
      . All patients with a serum ferritin value &lt;15ng/mL at week 4 visit that a second dose (of&#xD;
      500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control&#xD;
      Group:Placebo)&#xD;
&#xD;
      • Control Group Placebo will be in the form of normal saline administered over same time&#xD;
      period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection&#xD;
      with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus&#xD;
      injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus&#xD;
      injection) for body weight &lt;50 Kg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• Number of responders</measure>
    <time_frame>12 weeks post baseline</time_frame>
    <description>• Number of responders (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥11g/dL ) by 12 weeks (independent of alternative anaemia management including transfusion or ESA use). Note, if patient requires an ESA or blood transfusion by week 12 will be considered a non-responder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Percentage of patients with Hb ≥10, 11 and 12 g/dL</measure>
    <time_frame>3weeks , 12 weeks post baseline</time_frame>
    <description>• Percentage of patients with Hb ≥10, 11 and 12 g/dL at 3 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Percentage of patients requiring alternative anaemia management therapy</measure>
    <time_frame>12 weeks post baseline</time_frame>
    <description>• Percentage of patients requiring alternative anaemia management therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Self-reported patient assessment of EORTC QLQ C-30 and Sto-22</measure>
    <time_frame>3weeks, 12weeks post baseline</time_frame>
    <description>• Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Evolution of Hb, ferritin and TSAT</measure>
    <time_frame>12 weeks post baseline</time_frame>
    <description>• Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• adverse events: type, nature, incidence and outcome</measure>
    <time_frame>up to 3 weeks post baseline</time_frame>
    <description>• adverse events: type, nature, incidence and outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">454</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Ferinject® Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb&lt;10g/dl at 5 - 7 days after gastrectomy for gastric cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb&lt;10g/dl at 5 - 7 days after gastrectomy for gastric cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferinject®</intervention_name>
    <description>Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight &lt;50Kg .&#xD;
Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight &lt;50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value &lt;15ng/mL and Hb&lt;10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)</description>
    <arm_group_label>Ferinject® Group</arm_group_label>
    <other_name>Ferric carboxymaltose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight &lt;50 Kg.</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 20 years old&#xD;
&#xD;
          -  7g/dl ≤ Hb &lt; 10g/dl at 5 - 7 days after gastrectomy for gastric cancer&#xD;
&#xD;
          -  signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a concurrent medical condition(s) that would prevent compliance or participation or&#xD;
             jeopardize the health of the patient&#xD;
&#xD;
          -  hypersensitivity to any component of the formulation&#xD;
&#xD;
          -  active severe infection/inflammation&#xD;
&#xD;
          -  History of transfusion, erythropoietin, &gt; 500 mg intravenous iron administration&#xD;
             within 4 weeks prior to screening.&#xD;
&#xD;
          -  History of acquired iron overload.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Decreased renal function (defined as creatinine clearance &lt; 50 mL/min calculated by&#xD;
             Cockcroft-Gault)&#xD;
&#xD;
          -  Chronic liver disease or increase of liver enzymes (ALT, AST) &gt; 3 times the upper&#xD;
             limit of normal range.&#xD;
&#xD;
          -  Participation in any other interventional study within 1 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>
  <overall_official>
    <last_name>Young Woo Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Rep. of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Chollanam Do</state>
        <zip>519-763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-do</state>
        <zip>411-764</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook national university hospital</name>
      <address>
        <city>Dae Gu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Young-Woo Kim</investigator_full_name>
    <investigator_title>Head of Department of Gastric Cancer Research</investigator_title>
  </responsible_party>
  <keyword>Acute isovolemic anemia after gastrectomy for gastric cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</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/NCT01725789
org study id: NCCCTS-12-644
nct id: NCT01725789
lead sponsor: 
has dmc: Yes
This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic
      anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective
      measures (Hb and iron parameters).

      Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a
      cut-off value for our study based on the guidelines published by American Society of Clinical
      Oncology and the American Society of Hematology for the treatment of cancer-related anemia,
      recommending Hb<10 g/dl as a treatment threshold.

      Ferinject® to be administered based on Hb and body weight per approved summary of product
      characteristics (SmPC).

      5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb<10g/dl will
      be administered Ferinject® or placebo (normal saline) based on the results of randomization.

      • Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection
      with a minimum administration time of 15minutes (for 1000mg single administration) for body
      weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .

      Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients
      with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline
      . All patients with a serum ferritin value <15ng/mL at week 4 visit that a second dose (of
      500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control
      Group:Placebo)

      • Control Group Placebo will be in the form of normal saline administered over same time
      period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection
      with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus
      injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus
      injection) for body weight <50 Kg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: • Number of responders
time frame: 12 weeks post baseline
description: • Number of responders (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥11g/dL ) by 12 weeks (independent of alternative anaemia management including transfusion or ESA use). Note, if patient requires an ESA or blood transfusion by week 12 will be considered a non-responder.
measure: • Percentage of patients with Hb ≥10, 11 and 12 g/dL
time frame: 3weeks , 12 weeks post baseline
description: • Percentage of patients with Hb ≥10, 11 and 12 g/dL at 3 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use)
measure: • Percentage of patients requiring alternative anaemia management therapy
time frame: 12 weeks post baseline
description: • Percentage of patients requiring alternative anaemia management therapy
measure: • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22
time frame: 3weeks, 12weeks post baseline
description: • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks
measure: • Evolution of Hb, ferritin and TSAT
time frame: 12 weeks post baseline
description: • Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use
measure: • adverse events: type, nature, incidence and outcome
time frame: up to 3 weeks post baseline
description: • adverse events: type, nature, incidence and outcome
arm group label: Ferinject® Group
arm group type: Experimental
description: Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
intervention type: Drug
intervention name: Ferinject®
description: Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value <15ng/mL and Hb<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)
arm group label: Ferinject® Group
other name: Ferric carboxymaltose
intervention type: Drug
intervention name: normal saline
description: Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Young Woo Kim, PhD
role: Principal Investigator
affiliation: National Cancer Center, Rep. of Korea
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Young-Woo Kim
investigator title: Head of Department of Gastric Cancer Research
mesh term: Anemia