<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/NCT02232113</url>
  </required_header>
  <id_info>
    <org_study_id>2011-10-004IA</org_study_id>
    <nct_id>NCT02232113</nct_id>
  </id_info>
  <brief_title>Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients</brief_title>
  <official_title>The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taipei City Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose&#xD;
      interval and the survey for influence factors:&#xD;
&#xD;
      We aim to evaluate a better clinical response which can be achieved by different dosing&#xD;
      interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with&#xD;
      better clinical response to CERA and identify the associated factors predicting the&#xD;
      cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We included HD patients with stable hematocrit (between 30~36%) under intravenous&#xD;
      administration of CERA 100 μg once monthly for two months. Then they were shifted to receive&#xD;
      CERA 50μg twice monthly for anther two months and finally they were shifted back to receive&#xD;
      CERA 100 μg once monthly again for additional two months. Then we measured and compared the&#xD;
      erythropoietic response (hematocrit, hemoglobin), profiles of iron status as well as&#xD;
      nutritional status and inflammatory markers among the study subjects every two months for a&#xD;
      total of 6 months. Those who had bleeding or received surgery or blood transfusion were&#xD;
      excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 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>Erythropoietic response</measure>
    <time_frame>every 2 months for six months</time_frame>
    <description>We measured and compared the hematocrit, hemoglobin, and iron status profiles (ferritin, iron, total iron binding capacity) among those enrolled patients every 2 months for 6 months totally.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutritional status and inflammatory markers</measure>
    <time_frame>every 2 months for a total of 6 months</time_frame>
    <description>Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Anemia</condition>
  <condition>Inflammation</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>CERA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We included HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we compared the hematocrit, nutrition status and inflammation markers every two months for 6 months totally. Those who had bleeding or received surgery or blood transfusion were excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CERA</intervention_name>
    <description>changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA</description>
    <arm_group_label>CERA</arm_group_label>
    <other_name>Full name: Continuous Erythropoietic Receptor Activator</other_name>
    <other_name>Abbreviation : CERA</other_name>
    <other_name>Generic name: Methoxy polyethylene glycol-epoetin beta</other_name>
    <other_name>Brand name：Mircera®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HD patients with stable hematocrit (between 30~36%) under intravenous administration&#xD;
             of CERA 100 μg once monthly for two months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HD patients were excluded due to active bleeding (major trauma, gastric ulcer&#xD;
             bleeding, or surgery), blood transfusion or administration of additional&#xD;
             erythropoietic stimulating agent (ESA) other than CERA within the follow-up period&#xD;
             during the study perod of 6 months. People who discontinued CERA as their ESA were&#xD;
             also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chih-Ching Lin, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://www.roche.com/products/product-details.htm?type=product&amp;id=83</url>
    <description>Used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD).</description>
  </link>
  <reference>
    <citation>Liu WS, Wu YL, Li SY, Yang WC, Chen TW, Lin CC. The waveform fluctuation and the clinical factors of the initial and sustained erythropoietic response to continuous erythropoietin receptor activator in hemodialysis patients. ScientificWorldJournal. 2012;2012:157437. doi: 10.1100/2012/157437. Epub 2012 Apr 19.</citation>
    <PMID>22619601</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 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>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Chih-Ching Lin,M.D PhD.</investigator_title>
  </responsible_party>
  <keyword>malnutrition, inflammation, and anemia (MIA) syndrome,</keyword>
  <keyword>hemodialysis,</keyword>
  <keyword>erythropoietin stimulating agent (ESA),</keyword>
  <keyword>cost-effectiveness,</keyword>
  <keyword>pharmacokinetics,</keyword>
  <keyword>endothelial dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 8, 2014</submitted>
    <returned>November 14, 2014</returned>
  </pending_results>
  <!-- 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/NCT02232113
org study id: 2011-10-004IA
nct id: NCT02232113
lead sponsor: 
collaborator: 
has dmc: Yes
The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose
      interval and the survey for influence factors:

      We aim to evaluate a better clinical response which can be achieved by different dosing
      interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with
      better clinical response to CERA and identify the associated factors predicting the
      cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.
We included HD patients with stable hematocrit (between 30~36%) under intravenous
      administration of CERA 100 μg once monthly for two months. Then they were shifted to receive
      CERA 50μg twice monthly for anther two months and finally they were shifted back to receive
      CERA 100 μg once monthly again for additional two months. Then we measured and compared the
      erythropoietic response (hematocrit, hemoglobin), profiles of iron status as well as
      nutritional status and inflammatory markers among the study subjects every two months for a
      total of 6 months. Those who had bleeding or received surgery or blood transfusion were
      excluded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Erythropoietic response
time frame: every 2 months for six months
description: We measured and compared the hematocrit, hemoglobin, and iron status profiles (ferritin, iron, total iron binding capacity) among those enrolled patients every 2 months for 6 months totally.
measure: Nutritional status and inflammatory markers
time frame: every 2 months for a total of 6 months
description: Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]
arm group label: CERA
arm group type: Experimental
description: We included HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we compared the hematocrit, nutrition status and inflammation markers every two months for 6 months totally. Those who had bleeding or received surgery or blood transfusion were excluded.
intervention type: Drug
intervention name: CERA
description: changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
arm group label: CERA
other name: Full name: Continuous Erythropoietic Receptor Activator
other name: Abbreviation : CERA
other name: Generic name: Methoxy polyethylene glycol-epoetin beta
other name: Brand name：Mircera®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Chih-Ching Lin, MD, PhD
role: Study Director
affiliation: Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
facility: 
country: Taiwan
url: http://www.roche.com/products/product-details.htm?type=product&id=83
description: Used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD).
citation: Liu WS, Wu YL, Li SY, Yang WC, Chen TW, Lin CC. The waveform fluctuation and the clinical factors of the initial and sustained erythropoietic response to continuous erythropoietin receptor activator in hemodialysis patients. ScientificWorldJournal. 2012;2012:157437. doi: 10.1100/2012/157437. Epub 2012 Apr 19.
PMID: 22619601
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Chih-Ching Lin,M.D PhD.
mesh term: Malnutrition
mesh term: Inflammation
submitted: November 8, 2014
returned: November 14, 2014