<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/NCT01723111</url>
  </required_header>
  <id_info>
    <org_study_id>knuhhermes</org_study_id>
    <nct_id>NCT01723111</nct_id>
  </id_info>
  <brief_title>Impact of Dialysis Modality on Hepcidin and Iron Metabolism</brief_title>
  <acronym>HERMES</acronym>
  <official_title>A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fresenius Medical Care North America</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Dialysis modality may influence the oxidative stress and proinflammatory cytokines in&#xD;
           ESRD patients.&#xD;
&#xD;
        -  Dialysis modality may affect hepcidin&#xD;
&#xD;
        -  Dialysis modality may influence iron and ESA requirements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been considered that PD patients tended to be less anemic and require lower ESA dose&#xD;
      than HD patients. In addition, it was also known that the level of oxidative stress and&#xD;
      inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin&#xD;
      synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD&#xD;
      patients may be associated with lower hepcidin level due to lower inflammatory state compared&#xD;
      with HD patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ESA (Erythrocyte stimulating agents) dose</measure>
    <time_frame>six months</time_frame>
    <description>We will compare ESA dose between PD patients and HD patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IV iron treatment (% of patients)</measure>
    <time_frame>six months</time_frame>
    <description>We will compare IV iron treatment (% of patients) between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepcidin level</measure>
    <time_frame>six months</time_frame>
    <description>We will compare hepcidin level between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hs-CRP</measure>
    <time_frame>six months</time_frame>
    <description>We will compare hs-CRP level between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myeloperoxidase</measure>
    <time_frame>six months</time_frame>
    <description>We will compare myeloperoxidase between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion rate</measure>
    <time_frame>six months</time_frame>
    <description>We will compare transfusion rate ( % of patients) between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-a</measure>
    <time_frame>six months</time_frame>
    <description>We will compare TNF-a between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>six months</time_frame>
    <description>We will compare IL-6 between PD patients and HD patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total antioxidant capacity</measure>
    <time_frame>six months</time_frame>
    <description>We will compare total antioxidant capacity between PD patients and HD patients</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>End-stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Peritoneal dialysis</arm_group_label>
    <description>start PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemodialysis</arm_group_label>
    <description>start HD</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      2 ml serum will be retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        New ESRD patients whose dialysis treatment is expected over 3 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Dialysis treatment was expected over 3 months&#xD;
&#xD;
          -  In HD patients, regular hemodialysis 4 h a session more than two times a week&#xD;
&#xD;
          -  In PD patients, over 2 exchange with more than 1.5 L solution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite&#xD;
             medication requiring hospitalization or interruption of ESA treatment&#xD;
&#xD;
          -  Significant acute or chronic bleeding such as overt gastrointestinal bleeding within&#xD;
             the previous 3 months&#xD;
&#xD;
          -  Active malignant disease (except non-melanoma skin cancer and patients with malignant&#xD;
             disease who have been disease-free for at least the 5 previous years are eligible)&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  Hemolysis&#xD;
&#xD;
          -  Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)&#xD;
&#xD;
          -  Megaloblastic anemia&#xD;
&#xD;
          -  Platelet count &gt;500 x 109/L or &lt;100 x 109/L&#xD;
&#xD;
          -  Pure red call aplasia&#xD;
&#xD;
          -  Epileptic seizure during previous 3 months&#xD;
&#xD;
          -  Women of childbearing potential without effective contraception&#xD;
&#xD;
          -  Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol&#xD;
&#xD;
          -  Planned elective surgery during the study period except for cataract surgery or laser&#xD;
             photocoagulation&#xD;
&#xD;
          -  Life expectancy less than 12 month&#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>Yong-Lim Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Daegu Fatima Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University College of Medicine</name>
      <address>
        <city>Daegu</city>
        <zip>705-717</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Malyszko J, Malyszko JS, Kozminski P, Mysliwiec M. Type of renal replacement therapy and residual renal function may affect prohepcidin and hepcidin. Ren Fail. 2009;31(10):876-83. doi: 10.3109/08860220903216071.</citation>
    <PMID>20030521</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Yong-Lim Kim</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>hepcidin</keyword>
  <keyword>ESA</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>peritoneal dialysis</keyword>
  <keyword>iron metabolism</keyword>
  <keyword>dialysis modality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</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/NCT01723111
org study id: knuhhermes
nct id: NCT01723111
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
-  Dialysis modality may influence the oxidative stress and proinflammatory cytokines in
           ESRD patients.

        -  Dialysis modality may affect hepcidin

        -  Dialysis modality may influence iron and ESA requirements.
It has been considered that PD patients tended to be less anemic and require lower ESA dose
      than HD patients. In addition, it was also known that the level of oxidative stress and
      inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin
      synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD
      patients may be associated with lower hepcidin level due to lower inflammatory state compared
      with HD patients.
observational model: Case-Control
time perspective: Prospective
measure: ESA (Erythrocyte stimulating agents) dose
time frame: six months
description: We will compare ESA dose between PD patients and HD patients
measure: IV iron treatment (% of patients)
time frame: six months
description: We will compare IV iron treatment (% of patients) between PD patients and HD patients
measure: Hepcidin level
time frame: six months
description: We will compare hepcidin level between PD patients and HD patients
measure: hs-CRP
time frame: six months
description: We will compare hs-CRP level between PD patients and HD patients
measure: Myeloperoxidase
time frame: six months
description: We will compare myeloperoxidase between PD patients and HD patients
measure: Transfusion rate
time frame: six months
description: We will compare transfusion rate ( % of patients) between PD patients and HD patients
measure: TNF-a
time frame: six months
description: We will compare TNF-a between PD patients and HD patients
measure: IL-6
time frame: six months
description: We will compare IL-6 between PD patients and HD patients
measure: Total antioxidant capacity
time frame: six months
description: We will compare total antioxidant capacity between PD patients and HD patients
arm group label: Peritoneal dialysis
description: start PD
arm group label: Hemodialysis
description: start HD
2 ml serum will be retained
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yong-Lim Kim
role: Principal Investigator
affiliation: Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
citation: Malyszko J, Malyszko JS, Kozminski P, Mysliwiec M. Type of renal replacement therapy and residual renal function may affect prohepcidin and hepcidin. Ren Fail. 2009;31(10):876-83. doi: 10.3109/08860220903216071.
PMID: 20030521
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Yong-Lim Kim
investigator title: MD, PhD
mesh term: Kidney Failure, Chronic