<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/NCT02228655</url>
  </required_header>
  <id_info>
    <org_study_id>FX-C-888</org_study_id>
    <nct_id>NCT02228655</nct_id>
  </id_info>
  <brief_title>An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD</brief_title>
  <official_title>An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FerruMax Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FerruMax Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to recruit patients meeting eligibilty criteria.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Early Phase 1</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>Change in hemoglobin concentration</measure>
    <time_frame>57 day evaluation period</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Anemia in Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>FMX-8</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FMX-8 for injection, 15mg/kg, twice weekly, 29 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMX-8</intervention_name>
    <arm_group_label>FMX-8</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a documented hemoglobin level to be less than 10 g/dL at screening&#xD;
&#xD;
          -  diagnoses of CKD 4 or 5&#xD;
&#xD;
          -  body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height&#xD;
             and weight at screening&#xD;
&#xD;
          -  ferritin levels ≥100 ng/ml or Tsat ≥20% at screening&#xD;
&#xD;
          -  erythropoietin (EPO) level greater than 8 ng/mL&#xD;
&#xD;
          -  able to provide written informed consent&#xD;
&#xD;
          -  able to understand and follow all trial procedures&#xD;
&#xD;
          -  willing to use contraception as detailed in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  receipt of red blood cell (RBC) transfusion within four weeks before screening&#xD;
&#xD;
          -  overt gastrointestinal bleeding or other bleeding episode that required transfusion&#xD;
             within 2 months prior to screening&#xD;
&#xD;
          -  infection necessitating antibiotic or anti-viral treatment within a month prior to&#xD;
             screening&#xD;
&#xD;
          -  requiring Coumadin (warfarin), Pradaxa®, Eliquis®, or Xarelto®&#xD;
&#xD;
          -  hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types&#xD;
&#xD;
          -  active hemolysis or chronic hypoxia&#xD;
&#xD;
          -  active malignant diseases (except non-melanoma skin cancer) or life expectancy less&#xD;
             than 6 months&#xD;
&#xD;
          -  chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia&#xD;
             such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute&#xD;
             infection&#xD;
&#xD;
          -  on immunosuppressive therapeutics except topical corticosteroids or nasal sprays&#xD;
&#xD;
          -  chronic congestive heart failure (New York Heart Association Class III, IV)&#xD;
&#xD;
          -  significant hypertension (≥90 diastolic) based on a sitting diastolic blood pressure&#xD;
             at screening&#xD;
&#xD;
          -  kidney transplant within the past year: patients who are off immunosuppressive agents&#xD;
             following a failed transplant are eligible for the trial&#xD;
&#xD;
          -  end-stage liver disease&#xD;
&#xD;
          -  known hypersensitivity to recombinant protein therapies&#xD;
&#xD;
          -  female patients who are pregnant or breast feeding&#xD;
&#xD;
          -  previous exposure to FMX-8&#xD;
&#xD;
          -  previous exposure to Epogen®, Procrit® (erythropoietin) Aranesp® (darbepoietin alpha),&#xD;
             Omontys® or Hematide® (peginesatide) anemia treatment&#xD;
&#xD;
          -  uncontrolled hyperparathyroidism (PTH &gt;750) based upon latest PTH determination within&#xD;
             the past 4 months&#xD;
&#xD;
          -  inability to comply with the trial scheduled visits&#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>Stewart Lecker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY. Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. doi: 10.1038/ng1777. Epub 2006 Apr 9.</citation>
    <PMID>16604073</PMID>
  </reference>
  <reference>
    <citation>Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY. Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9. doi: 10.1172/JCI31342.</citation>
    <PMID>17607365</PMID>
  </reference>
  <reference>
    <citation>Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC. A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91. doi: 10.1172/JCI25049.</citation>
    <PMID>16075059</PMID>
  </reference>
  <reference>
    <citation>KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008. No abstract available.</citation>
    <PMID>17720528</PMID>
  </reference>
  <reference>
    <citation>Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5.</citation>
    <PMID>21730356</PMID>
  </reference>
  <reference>
    <citation>Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.</citation>
    <PMID>15758012</PMID>
  </reference>
  <reference>
    <citation>Weiner DE. Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. doi: 10.18553/jmcp.2007.13.s3.1.</citation>
    <PMID>17402808</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>CKD</keyword>
  <keyword>Anemia of Chronic Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</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/NCT02228655
org study id: FX-C-888
nct id: NCT02228655
lead sponsor: 
has dmc: No
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in hemoglobin concentration
time frame: 57 day evaluation period
arm group label: FMX-8
arm group type: Other
description: FMX-8 for injection, 15mg/kg, twice weekly, 29 days
intervention type: Drug
intervention name: FMX-8
arm group label: FMX-8
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stewart Lecker, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
citation: Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY. Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. doi: 10.1038/ng1777. Epub 2006 Apr 9.
PMID: 16604073
citation: Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY. Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9. doi: 10.1172/JCI31342.
PMID: 17607365
citation: Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC. A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91. doi: 10.1172/JCI25049.
PMID: 16075059
citation: KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008. No abstract available.
PMID: 17720528
citation: Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5.
PMID: 21730356
citation: Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PMID: 15758012
citation: Weiner DE. Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. doi: 10.18553/jmcp.2007.13.s3.1.
PMID: 17402808
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia