<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/NCT02977611</url>
  </required_header>
  <id_info>
    <org_study_id>1611-56</org_study_id>
    <nct_id>NCT02977611</nct_id>
  </id_info>
  <brief_title>The Safety of a High-Dose, Rapid Infusion of Iron Sucrose</brief_title>
  <official_title>The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough&#xD;
      iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce&#xD;
      hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it&#xD;
      cannot produce enough hemoglobin and you become anemic.&#xD;
&#xD;
      The research study is looking at the side effects of using a higher dose and faster rate of&#xD;
      iron sucrose infusion than what is used in standard of care. The purpose of this study is to&#xD;
      see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely.&#xD;
      If this can be done safely, it may reduce the total number of infusions required and the time&#xD;
      for each infusion. This may be less costly and less burdensome to patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    FDA Clinical Hold&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of adverse events in the study population attributed to drug administration.</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>High Dose, Rapid Infusion Iron Sucrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron sucrose</intervention_name>
    <description>Iron sucrose will be infused at dose of 500 mg over a one hour period</description>
    <arm_group_label>High Dose, Rapid Infusion Iron Sucrose</arm_group_label>
    <other_name>Venofer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient requiring iron infusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from enrollment if they are under the age of 18, unable to&#xD;
             give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis&#xD;
             (HD), or have a history of clinically significant adverse reactions to iron sucrose.&#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>Bradley Lash, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Guthrie Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 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>Iron Deficiencies</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>
  <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/NCT02977611
org study id: 1611-56
nct id: NCT02977611
lead sponsor: 
has dmc: Yes
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough
      iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce
      hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it
      cannot produce enough hemoglobin and you become anemic.

      The research study is looking at the side effects of using a higher dose and faster rate of
      iron sucrose infusion than what is used in standard of care. The purpose of this study is to
      see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely.
      If this can be done safely, it may reduce the total number of infusions required and the time
      for each infusion. This may be less costly and less burdensome to patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: incidence of adverse events in the study population attributed to drug administration.
time frame: 4 hours
arm group label: High Dose, Rapid Infusion Iron Sucrose
arm group type: Experimental
description: Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.
intervention type: Drug
intervention name: Iron sucrose
description: Iron sucrose will be infused at dose of 500 mg over a one hour period
arm group label: High Dose, Rapid Infusion Iron Sucrose
other name: Venofer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bradley Lash, MD
role: Principal Investigator
affiliation: The Guthrie Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Iron Deficiencies
mesh term: Ferric Oxide, Saccharated
sharing ipd: No