<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/NCT02232906</url>
  </required_header>
  <id_info>
    <org_study_id>FCM-ND-CKD 2012</org_study_id>
    <nct_id>NCT02232906</nct_id>
  </id_info>
  <brief_title>Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)</brief_title>
  <official_title>Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Aleman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vifor Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Aleman</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce&#xD;
      dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron&#xD;
      status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron&#xD;
      schedule for 6 months prior to enrolment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anaemia and iron status</measure>
    <time_frame>6 months</time_frame>
    <description>Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of transfusions</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse reactions</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria at baseline and then bi-monthly until end of study as marker of renal function</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Iron Deficiency</condition>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>intravenous ferric carboxymaltose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravenous ferric carboxymaltose</intervention_name>
    <description>Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation &gt;20%)</description>
    <arm_group_label>intravenous ferric carboxymaltose</arm_group_label>
    <other_name>Ferinject, Injectafer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Creatinine clearance ≤40 mL/min&#xD;
&#xD;
          -  Hemoglobin 110-120 g/L&#xD;
&#xD;
          -  Serum ferritin &lt;100 µg/L or transferrin saturation &lt;20%&#xD;
&#xD;
          -  Monthly treatment with ESA and oral iron for at least six months before enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other obvious cause of acute or chronic anemia than iron deficiency&#xD;
&#xD;
          -  Expectation to require hemodialysis within the next six months&#xD;
&#xD;
          -  Short life expectancy (&lt;1 year)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Decompensated heart failure&#xD;
&#xD;
          -  History of allergic reactions to iron preparations and/or anaphylaxis from any cause&#xD;
&#xD;
          -  Requirement of blood transfusions&#xD;
&#xD;
          -  Chronic decompensated mental disorder or dementia&#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>Jorge E Toblli, Prof., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Aleman</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Alemán</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1118</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Aleman</investigator_affiliation>
    <investigator_full_name>Jorge Eduardo Toblli</investigator_full_name>
    <investigator_title>Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires.</investigator_title>
  </responsible_party>
  <keyword>Chronic kidney disease</keyword>
  <keyword>CKD</keyword>
  <keyword>non-dialysis-dependent</keyword>
  <keyword>ND-CKD</keyword>
  <keyword>Erythropoiesis-stimulating agent</keyword>
  <keyword>Ferric carboxymaltose</keyword>
  <keyword>Iron</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Iron Deficiencies</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/NCT02232906
org study id: FCM-ND-CKD 2012
nct id: NCT02232906
lead sponsor: 
collaborator: 
has dmc: No
Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce
      dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron
      status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron
      schedule for 6 months prior to enrolment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
time frame: 6 months
measure: Anaemia and iron status
time frame: 6 months
description: Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study
measure: Number of hospitalizations
time frame: 6 months
measure: Number of transfusions
time frame: 6 months
measure: Number of adverse reactions
time frame: 6 months
measure: Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
time frame: 6 months
measure: Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
time frame: 6 months
arm group label: intravenous ferric carboxymaltose
arm group type: Experimental
intervention type: Drug
intervention name: intravenous ferric carboxymaltose
description: Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%)
arm group label: intravenous ferric carboxymaltose
other name: Ferinject, Injectafer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge E Toblli, Prof., MD
role: Principal Investigator
affiliation: Hospital Aleman
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Hospital Aleman
investigator full name: Jorge Eduardo Toblli
investigator title: Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires.
mesh term: Anemia
mesh term: Iron Deficiencies