<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/NCT02243735</url>
  </required_header>
  <id_info>
    <org_study_id>NL50013.018.14</org_study_id>
    <secondary_id>2014-002827-87</secondary_id>
    <nct_id>NCT02243735</nct_id>
  </id_info>
  <brief_title>Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia</brief_title>
  <acronym>FIT</acronym>
  <official_title>Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vifor Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this multicenter trial is to determine the efficacy of preoperative intravenous&#xD;
      iron suppletion in comparison with the standard preoperative oral substitution in anaemic&#xD;
      patients with colorectal cancer in curing the anemia and the assess the effect of&#xD;
      preoperative iron on morbidity, postoperative recovery and quality of life.&#xD;
&#xD;
      Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with&#xD;
      intravenous iron will lead to a higher percentage of patients with normalization of Hb-level&#xD;
      (&gt; 12 g/dl (7.5 mmol/l) for women and &gt; 13 g/dl (8 mmol/l) for men), which potentially&#xD;
      reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be&#xD;
      more cost effective compared to current practice with oral substitution of iron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter randomized clinical trial aims to optimize postoperative outcome in anaemic&#xD;
      patients who undergo curative surgery for colorectal carcinoma. The aim of this trial is to&#xD;
      investigate which route of administration is superior in the treatment of iron deficiency&#xD;
      anaemia in these patients. In addition, an economic evaluation of intravenous iron versus&#xD;
      oral iron will be done. The evaluation will be performed from a societal perspective as (i) a&#xD;
      cost-effectiveness analysis with the costs per responder to iron suppletion therapy as&#xD;
      primary outcome and (ii) a cost-utility analysis with the costs per quality adjusted&#xD;
      life-year (QALY) as primary outcome. The cost effectiveness analysis closely relates to&#xD;
      clinical efficacy measure and allows for setting priorities in treatment of anaemia in&#xD;
      colorectal cancer patients. The cost-utility analysis allows for a comparison of the societal&#xD;
      impact of intravenous iron suppletion on post-operative recovery, such as shorter length of&#xD;
      stay and earlier return to daily activities, with the impact of other interventions and of&#xD;
      interventions in other areas of health care.&#xD;
&#xD;
      The primary aim of this trial is:&#xD;
&#xD;
        1. To compare the percentage of patients with normalization of Hb-level (&gt; 12 g/dl (7.5&#xD;
           mmol/l) for women and &gt; 13 g/dl (8 mmol/l) for men after intravenous versus oral iron&#xD;
           therapy in patients undergoing curative surgery for colorectal carcinoma.&#xD;
&#xD;
           Secondary aims of the FIT trial are:&#xD;
&#xD;
        2. To analyse the effect of preoperative iron therapy (intravenous versus oral) on&#xD;
           postoperative morbidity, length of stay, amount of blood transfusions needed and quality&#xD;
           of life and fatigue scores.&#xD;
&#xD;
        3. To determine the cost effectiveness of preoperative intravenous iron substitution in&#xD;
           comparison with oral substitution.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The principal analysis will consist of an intention-to-treat comparison of the proportions of&#xD;
      patients with iron deficiency anaemia between the two study groups. The trial is designed as&#xD;
      a superiority trial, hypothesizing a greater percentage of patients achieving normalization&#xD;
      of Hb-level (called 'responder') in favour of infusion of ferric(III)carboxymaltose compared&#xD;
      to oral iron suppletion. Our power calculation is based on the study of Seid et al(19), which&#xD;
      compared ferric(III)carboxymaltose with oral ferrous sulphate in a population of post-partum&#xD;
      women with an iron deficiency anaemia. The proportion achieving a normalization of Hb after&#xD;
      two weeks of treatment was 55% in the intravenous iron group and 35% in the oral iron group.&#xD;
      We expect that the efficacy of the iron therapy is lower in patients with a colorectal&#xD;
      carcinoma. Therefore, the expected percentage of patients who achieve normalization of&#xD;
      Hb-level (Hb &gt;7.5 mmol/l (12 g/dl) for women and Hb &gt;8.o mmol/l (13 g/dl) for men) is 45% in&#xD;
      the intravenous iron group and 25% in the oral iron group. Based on these proportions, a&#xD;
      sample size of 89 patients per group is needed for a Chi square test to achieve 80% power at&#xD;
      a two sided alpha of 0.05. With an estimated loss to follow up of 10%, a sample size of 198&#xD;
      is calculated. We used nQuery advisor version 7.0 to calculate the sample size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Normalization of Hb-level.</measure>
    <time_frame>From Baseline (date of randomisation) untill day of admission for surgery</time_frame>
    <description>Percentage of patients with normalization of Hb-level from start treatment until day of admission for surgery. (Hb &gt;12g/dl (7.5mmol/L) for women and Hb &gt;13 g/dl (8.0mmol/L) for men).&#xD;
Patient will be randomised after they visit the surgery outpatient clinic to discuss the treatment option for their colorectal carcinoma. Average time between this visit and surgery in the Netherlands is maximally 5 weeks. Patients on oral iron suppletion will start with the iron therapy on the day of the randomisation. For the patients that will receive intravenous iron an appointment will be made on the short-care unit to facilitate the infusion of the iron. The period between infusion and surgery should be longer than two weeks.&#xD;
Our primary endpoint: Percentage of patients with normalization of Hb-level. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Morbidity score</measure>
    <time_frame>postoperative at week 1, week 4, week 8 and week 12</time_frame>
    <description>The difference in morbidity score will be assessed using the Comprehensive Complication index, between both study groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">198</enrollment>
  <condition>Anemia</condition>
  <condition>Colorectal Carcinoma</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Ferrous fumarate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferric(III)carboxymaltose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous fumarate</intervention_name>
    <description>Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery</description>
    <arm_group_label>Ferrous fumarate</arm_group_label>
    <other_name>ferrofumarate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ferric(III)carboxymaltose</intervention_name>
    <description>Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered</description>
    <arm_group_label>ferric(III)carboxymaltose</arm_group_label>
    <other_name>Ferinject</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  M0-stage Colorectal carcinoma&#xD;
&#xD;
          -  Laparoscopic or open segmental colonic resection or (low) anterior resection&#xD;
&#xD;
          -  Iron deficiency anaemia: Hb &lt;7,5 mmol/l (12 g/dl) for women and Hb &lt; 8 mmol/l (13&#xD;
             g/dl) for men and TSAT&lt;20%&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Written informed consent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Palliative surgery / metastasized disease&#xD;
&#xD;
          -  Received blood transfusion within one month before screening&#xD;
&#xD;
          -  Serum ferritin ≥ 800 µg/L&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Preoperative chemoradiation (Short course radiotherapy (5x5 Gy) = no exclusion)&#xD;
&#xD;
          -  Contraindication for the use of ferric(III)carboxymaltose or ferrofumarate&#xD;
&#xD;
          -  ASA classification &gt; 3&#xD;
&#xD;
          -  Use of erythropoietin stimulating agents within three months before screening&#xD;
&#xD;
          -  Chronic kidney disease (GFR &lt; 30ml/min/m)&#xD;
&#xD;
          -  Myelodysplastic syndrome&#xD;
&#xD;
          -  Severe anaemia with indication for blood transfusion&#xD;
&#xD;
          -  Elevated liver enzymes (more than three times normal value)&#xD;
&#xD;
          -  Hereditary Hemochromatosis&#xD;
&#xD;
          -  Thalassemia&#xD;
&#xD;
          -  Haemolytic anaemia/ chronic haemolysis&#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>W. A Bemelman, Proffessor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wernard A Borstlap, MD</last_name>
    <phone>0031-(0)20- 5662670</phone>
    <email>w.a.borstlap@amc.uva.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Willem A Bemelman, Prof.</last_name>
    <phone>0031-(0)20- 5662766</phone>
    <email>w.a.bemelman@amc.uva.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medisch Centrum Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>L Houdijk, MD</last_name>
      <email>a.p.j.houdijk@mca.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Flevoziekenhuis</name>
      <address>
        <city>Almere</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>A Van de ven</last_name>
      <email>a.w.vandeven@amc.uva.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Meander Ziekenhuis</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>E Consten</last_name>
      <email>ECJ.Consten@meandermc.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wernard Borstlap</last_name>
      <email>w.a.borstlap@amc.uva.nl</email>
    </contact>
    <investigator>
      <last_name>willem bemelman, md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M Gerhards, MD</last_name>
      <email>m.f.gerhards@olvg.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sint Lucas Andreas Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Bart van Wagensveld, Md, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Spaarne ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Q Eijsbouts, MD</last_name>
      <email>qeijsbouts@spaarneziekenhuis.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VU medical center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jurriaan Tuynman, MD</last_name>
      <email>j.tuynman@vumc.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gelre Ziekenhuis</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>E. van der Zaag, MD</last_name>
      <email>e.van.der.zaag@gelre.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Albert Schweizer Ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>J van der Hoeven, MD</last_name>
      <email>.a.b.vander.hoeven@asz.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tergooi ziekenhuis</name>
      <address>
        <city>Hilversum</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>N van geloven, MD</last_name>
      <email>avangeloven@tergooi.nl)</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haga Ziekenhuis</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>W Steup, MD</last_name>
      <email>w.steup@hagaziekenhuis.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof. dr. W.A. Bemelman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferrous fumarate</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/NCT02243735
org study id: NL50013.018.14
secondary id: 2014-002827-87
nct id: NCT02243735
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous
      iron suppletion in comparison with the standard preoperative oral substitution in anaemic
      patients with colorectal cancer in curing the anemia and the assess the effect of
      preoperative iron on morbidity, postoperative recovery and quality of life.

      Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with
      intravenous iron will lead to a higher percentage of patients with normalization of Hb-level
      (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially
      reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be
      more cost effective compared to current practice with oral substitution of iron.
This multicenter randomized clinical trial aims to optimize postoperative outcome in anaemic
      patients who undergo curative surgery for colorectal carcinoma. The aim of this trial is to
      investigate which route of administration is superior in the treatment of iron deficiency
      anaemia in these patients. In addition, an economic evaluation of intravenous iron versus
      oral iron will be done. The evaluation will be performed from a societal perspective as (i) a
      cost-effectiveness analysis with the costs per responder to iron suppletion therapy as
      primary outcome and (ii) a cost-utility analysis with the costs per quality adjusted
      life-year (QALY) as primary outcome. The cost effectiveness analysis closely relates to
      clinical efficacy measure and allows for setting priorities in treatment of anaemia in
      colorectal cancer patients. The cost-utility analysis allows for a comparison of the societal
      impact of intravenous iron suppletion on post-operative recovery, such as shorter length of
      stay and earlier return to daily activities, with the impact of other interventions and of
      interventions in other areas of health care.

      The primary aim of this trial is:

        1. To compare the percentage of patients with normalization of Hb-level (> 12 g/dl (7.5
           mmol/l) for women and > 13 g/dl (8 mmol/l) for men after intravenous versus oral iron
           therapy in patients undergoing curative surgery for colorectal carcinoma.

           Secondary aims of the FIT trial are:

        2. To analyse the effect of preoperative iron therapy (intravenous versus oral) on
           postoperative morbidity, length of stay, amount of blood transfusions needed and quality
           of life and fatigue scores.

        3. To determine the cost effectiveness of preoperative intravenous iron substitution in
           comparison with oral substitution.

      Sample size:

      The principal analysis will consist of an intention-to-treat comparison of the proportions of
      patients with iron deficiency anaemia between the two study groups. The trial is designed as
      a superiority trial, hypothesizing a greater percentage of patients achieving normalization
      of Hb-level (called 'responder') in favour of infusion of ferric(III)carboxymaltose compared
      to oral iron suppletion. Our power calculation is based on the study of Seid et al(19), which
      compared ferric(III)carboxymaltose with oral ferrous sulphate in a population of post-partum
      women with an iron deficiency anaemia. The proportion achieving a normalization of Hb after
      two weeks of treatment was 55% in the intravenous iron group and 35% in the oral iron group.
      We expect that the efficacy of the iron therapy is lower in patients with a colorectal
      carcinoma. Therefore, the expected percentage of patients who achieve normalization of
      Hb-level (Hb >7.5 mmol/l (12 g/dl) for women and Hb >8.o mmol/l (13 g/dl) for men) is 45% in
      the intravenous iron group and 25% in the oral iron group. Based on these proportions, a
      sample size of 89 patients per group is needed for a Chi square test to achieve 80% power at
      a two sided alpha of 0.05. With an estimated loss to follow up of 10%, a sample size of 198
      is calculated. We used nQuery advisor version 7.0 to calculate the sample size.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Normalization of Hb-level.
time frame: From Baseline (date of randomisation) untill day of admission for surgery
description: Percentage of patients with normalization of Hb-level from start treatment until day of admission for surgery. (Hb >12g/dl (7.5mmol/L) for women and Hb >13 g/dl (8.0mmol/L) for men).
Patient will be randomised after they visit the surgery outpatient clinic to discuss the treatment option for their colorectal carcinoma. Average time between this visit and surgery in the Netherlands is maximally 5 weeks. Patients on oral iron suppletion will start with the iron therapy on the day of the randomisation. For the patients that will receive intravenous iron an appointment will be made on the short-care unit to facilitate the infusion of the iron. The period between infusion and surgery should be longer than two weeks.
Our primary endpoint: Percentage of patients with normalization of Hb-level. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks.
measure: Difference in Morbidity score
time frame: postoperative at week 1, week 4, week 8 and week 12
description: The difference in morbidity score will be assessed using the Comprehensive Complication index, between both study groups
arm group label: Ferrous fumarate
arm group type: Active Comparator
description: Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
arm group label: ferric(III)carboxymaltose
arm group type: Active Comparator
description: Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered
intervention type: Drug
intervention name: Ferrous fumarate
description: Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
arm group label: Ferrous fumarate
other name: ferrofumarate
intervention type: Drug
intervention name: ferric(III)carboxymaltose
description: Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered
arm group label: ferric(III)carboxymaltose
other name: Ferinject
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: W. A Bemelman, Proffessor
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Wernard A Borstlap, MD
phone: 0031-(0)20- 5662670
email: w.a.borstlap@amc.uva.nl
last name: Willem A Bemelman, Prof.
phone: 0031-(0)20- 5662766
email: w.a.bemelman@amc.uva.nl
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof. dr. W.A. Bemelman
investigator title: Professor
mesh term: Colorectal Neoplasms
mesh term: Anemia
mesh term: Ferrous fumarate