<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/NCT03286205</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03286205</nct_id>
  </id_info>
  <brief_title>A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.</brief_title>
  <official_title>A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sutter Gould Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sutter Gould Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is&#xD;
      superior for the treatment of iron deficient anemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is&#xD;
      superior for the treatment of iron deficient anemia. The two dosing regimens under review are&#xD;
      a low dose weekly or a larger dose given every three weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IP unavailable at site.&#xD;
  </why_stopped>
  <start_date type="Actual">April 14, 2015</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>superior dosing regimen exists for INfed</measure>
    <time_frame>3 years</time_frame>
    <description>shown by a 2gm/dl increase in HgB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Dose Effect</measure>
    <time_frame>3 years</time_frame>
    <description>INfed can be given at high dose without an increase in AE and/or SAEs frequency</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anemia, Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Weekly Dosage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>weekly dose of 100mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 week dosage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>every 3 week dosage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV iron</intervention_name>
    <description>IV iron infusion based on weekly or every 3 week dosage.</description>
    <arm_group_label>3 week dosage</arm_group_label>
    <arm_group_label>Weekly Dosage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients over the age of 18 years old.&#xD;
&#xD;
          2. Being treated by a Sutter Health Physician.&#xD;
&#xD;
          3. Hemoglobin of &lt; 10mg/dl for Men and Women&#xD;
&#xD;
          4. Ferritin &lt;/= 10ng/ml&#xD;
&#xD;
          5. Patients in whom oral administration is unsatisfactory or impossible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of receiving iron or other hematinic in the preceding 3&#xD;
             months, oral iron is allowable.&#xD;
&#xD;
          2. Anemia due to acute blood loss; menorrhagia is allowed.&#xD;
&#xD;
          3. Patients with a current illness known to interact with iron status.&#xD;
&#xD;
          4. Patients unwilling to consent to required blood draws.&#xD;
&#xD;
          5. Patients who are viewed as unable to complete treatment, based on PI recommendation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Adkins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sutter Gould Medical Foundation</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sutter Gould Medical Foundation</investigator_affiliation>
    <investigator_full_name>David Adkins</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_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/NCT03286205
org study id: 001
nct id: NCT03286205
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is
      superior for the treatment of iron deficient anemia.
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is
      superior for the treatment of iron deficient anemia. The two dosing regimens under review are
      a low dose weekly or a larger dose given every three weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: superior dosing regimen exists for INfed
time frame: 3 years
description: shown by a 2gm/dl increase in HgB
measure: High Dose Effect
time frame: 3 years
description: INfed can be given at high dose without an increase in AE and/or SAEs frequency
arm group label: Weekly Dosage
arm group type: Active Comparator
description: weekly dose of 100mg
arm group label: 3 week dosage
arm group type: Active Comparator
description: every 3 week dosage.
intervention type: Drug
intervention name: IV iron
description: IV iron infusion based on weekly or every 3 week dosage.
arm group label: 3 week dosage
arm group label: Weekly Dosage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Adkins, MD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sutter Gould Medical Foundation
investigator full name: David Adkins
investigator title: Principal Investigator
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No