<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/NCT03774615</url>
  </required_header>
  <id_info>
    <org_study_id>ORION-LVAD-1</org_study_id>
    <nct_id>NCT03774615</nct_id>
  </id_info>
  <brief_title>ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices</brief_title>
  <acronym>ORION-LVAD-1</acronym>
  <official_title>A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shields, Shields and Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hannover Medical School</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>
      This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to&#xD;
      detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron&#xD;
      deficiency anemia treated with oral ferric maltol for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low recruitment rate; difficulties to achieve planned number of participants within reasonable&#xD;
    time frame&#xD;
  </why_stopped>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">November 29, 2019</completion_date>
  <primary_completion_date type="Actual">November 29, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>open-label, uncontrolled, monocenter, phase IV study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To detect AEs and SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks</measure>
    <time_frame>baseline to week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin level from baseline to week 12</measure>
    <time_frame>baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin level from baseline to week 6</measure>
    <time_frame>baseline to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum ferritin levels and transferrin saturation from baseline to week 6</measure>
    <time_frame>baseline to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum ferritin levels and transferrin saturation from baseline to week 12</measure>
    <time_frame>baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 min walking distance from baseline to week 12</measure>
    <time_frame>baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum NT-proBNP from baseline to weeks 6</measure>
    <time_frame>baseline to weeks 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum NT-proBNP from baseline to weeks 12</measure>
    <time_frame>baseline to weeks 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)</measure>
    <time_frame>change from baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left atrial area, left ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)</measure>
    <time_frame>change from baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12</measure>
    <time_frame>from baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6</measure>
    <time_frame>from baseline to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12</measure>
    <time_frame>from baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6</measure>
    <time_frame>from baseline to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA from baseline to week 12</measure>
    <time_frame>from baseline to week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Heart Failure, Left Sided</condition>
  <condition>Anemia, Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Ferric maltol 30 mg (Feraccru®)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric maltol 30 mg (Feraccru®)</intervention_name>
    <description>Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects</description>
    <arm_group_label>Ferric maltol 30 mg (Feraccru®)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written informed consent prior to any study-related procedure and willingness&#xD;
             to comply with treatment and follow-up procedures&#xD;
&#xD;
          2. Male and female patients ≥18 years at day of inclusion&#xD;
&#xD;
          3. Patients capable of understanding the investigational nature, potential risks and&#xD;
             benefits of the clinical trial&#xD;
&#xD;
          4. Patients that have an LVAD implanted for chronic heart failure and which are&#xD;
             clinically stable for at least 6 months after LVAD implantation in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          5. 6 min walk distance &gt;50 m&#xD;
&#xD;
          6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7&#xD;
             g/dl and &lt;12 g/dl in females or ≥8 g/dl and &lt;13 g/dl in males, and serum ferritin &lt;100&#xD;
             µg/l, or 100-300 µg/l and transferrin saturation &lt;20% at screening&#xD;
&#xD;
          7. Women of childbearing potential must:&#xD;
&#xD;
        Have a negative pregnancy test at screening Agree to use reliable methods of contraception&#xD;
        during the course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active hematological disorders other than iron-deficiency anemia&#xD;
&#xD;
          2. Other medical condition that according to the investigator's assessment is causing or&#xD;
             contributing to anemia&#xD;
&#xD;
          3. Active malignancy&#xD;
&#xD;
          4. Active infectious disease&#xD;
&#xD;
          5. Active bleeding&#xD;
&#xD;
          6. Severe renal insufficiency (requiring dialysis)&#xD;
&#xD;
          7. Severe liver injury as indicated by serum aminotransferases &gt;3 x upper limit of normal&#xD;
             or bilirubin levels &gt;50 µmol/l&#xD;
&#xD;
          8. Ongoing oral or intravenous iron supplementation&#xD;
&#xD;
          9. Concomitant erythropoietin medication&#xD;
&#xD;
         10. Pregnancy or lactation period&#xD;
&#xD;
         11. Subject has received any investigational medication or any investigational devices&#xD;
             within 30 days prior to the first dose of study medication or is actively&#xD;
             participating in any investigational drug/ devices trial, or is scheduled to receive&#xD;
             investigational drug/devices during the course of the study.&#xD;
&#xD;
         12. Known or suspected hypersensitivity to any of the active substances or any excipients&#xD;
             of the investigational medicinal product&#xD;
&#xD;
         13. Known haemochromatosis or other iron overload syndromes&#xD;
&#xD;
         14. Patients who have been receiving repeated (&gt;1) blood transfusions during the past 6&#xD;
             months&#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>Jan Schmitto, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iron Deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferric maltol</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/NCT03774615
org study id: ORION-LVAD-1
nct id: NCT03774615
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to
      detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron
      deficiency anemia treated with oral ferric maltol for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open-label, uncontrolled, monocenter, phase IV study
primary purpose: Treatment
masking: None (Open Label)
measure: To detect AEs and SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks
time frame: baseline to week 12
measure: Change in hemoglobin level from baseline to week 12
time frame: baseline to week 12
measure: Change in hemoglobin level from baseline to week 6
time frame: baseline to week 6
measure: Change in serum ferritin levels and transferrin saturation from baseline to week 6
time frame: baseline to week 6
measure: Change in serum ferritin levels and transferrin saturation from baseline to week 12
time frame: baseline to week 12
measure: Change in 6 min walking distance from baseline to week 12
time frame: baseline to week 12
measure: Change in serum NT-proBNP from baseline to weeks 6
time frame: baseline to weeks 6
measure: Change in serum NT-proBNP from baseline to weeks 12
time frame: baseline to weeks 12
measure: Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)
time frame: change from baseline to week 12
measure: Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left atrial area, left ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)
time frame: change from baseline to week 12
measure: Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12
time frame: from baseline to week 12
measure: Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6
time frame: from baseline to week 6
measure: Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12
time frame: from baseline to week 12
measure: Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6
time frame: from baseline to week 6
measure: Change in NYHA from baseline to week 12
time frame: from baseline to week 12
arm group label: Ferric maltol 30 mg (Feraccru®)
arm group type: Experimental
description: Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks
intervention type: Drug
intervention name: Ferric maltol 30 mg (Feraccru®)
description: Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects
arm group label: Ferric maltol 30 mg (Feraccru®)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Schmitto, Prof. MD
role: Principal Investigator
affiliation: Hannover Medical School
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Ferric maltol