<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/NCT01719146</url>
  </required_header>
  <id_info>
    <org_study_id>12.0149</org_study_id>
    <secondary_id>R01DK093832</secondary_id>
    <nct_id>NCT01719146</nct_id>
  </id_info>
  <brief_title>Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease</brief_title>
  <official_title>Computational Approach to Personalized Anemia Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prospectively collect data on doses of Erythropoietic&#xD;
      Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and&#xD;
      iron status. These data will be used to derive mathematical models which will subsequently&#xD;
      guide dosing of both agents, such that a desired therapeutic outcome is achieved in every&#xD;
      patient, while minimizing patient exposure to both agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical&#xD;
      sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek&#xD;
      treatment (Wed/Thu) to measure:&#xD;
&#xD;
      Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte&#xD;
      Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin&#xD;
      Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum&#xD;
      Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor&#xD;
&#xD;
      Weekly ESA and Iron dose delivered will also be recorded.&#xD;
&#xD;
      From these data:&#xD;
&#xD;
        1. a mathematical model will be established to find biomarkers most descriptive with&#xD;
           respect to erythropoiesis-iron synergy,&#xD;
&#xD;
        2. a mathematical model will be established to correlate iron dose with iron markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 5, 2021</completion_date>
  <primary_completion_date type="Actual">June 5, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin Concentration (g/dL)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Weekly Hemoglobin Concentration</description>
  </primary_outcome>
  <other_outcome>
    <measure>Transferrin Saturation (%)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Weekly Transferrin Saturation</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Ferritin (ng/mL)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Weekly Serum Ferritin</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">134</enrollment>
  <condition>Anemia of End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>UofL Subjects</arm_group_label>
    <description>Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duke Subjects</arm_group_label>
    <description>Subjects undergoing Specimen Collection at Duke University, Durham, NC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WNERTA Subjects</arm_group_label>
    <description>Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specimen collection</intervention_name>
    <description>At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.</description>
    <arm_group_label>Duke Subjects</arm_group_label>
    <arm_group_label>UofL Subjects</arm_group_label>
    <arm_group_label>WNERTA Subjects</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, serum will be extracted and frozen for further analysis. Serum will be retained for up&#xD;
      to 60 days.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        End Stage Renal Disease Patients undergoing hemodialysis treatments at:&#xD;
&#xD;
          1. University Kidney Center, Louisville, KY&#xD;
&#xD;
          2. Duke University, Durham, NC&#xD;
&#xD;
          3. WNERTA, Springfield, MA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  receiving or expected to receive ESA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  life expectancy less than 12 months&#xD;
&#xD;
          -  frequent (once or more per month w/in last 6 months) uncontrolled blood loss&#xD;
&#xD;
          -  frequent (once or more per month w/in last 6 months) hospitalization&#xD;
&#xD;
          -  frequent (once or more per month w/in last 6 months) access complications&#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>Adam E Gaweda, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville, University Kidney Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western New England Renal and Transplant Associates</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Adam Edward Gaweda</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Anemia</keyword>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Erythropoiesis Stimulating Agents</keyword>
  <keyword>Erythropoietin</keyword>
  <keyword>Iron</keyword>
  <keyword>Iron Deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01719146
org study id: 12.0149
secondary id: R01DK093832
nct id: NCT01719146
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to prospectively collect data on doses of Erythropoietic
      Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and
      iron status. These data will be used to derive mathematical models which will subsequently
      guide dosing of both agents, such that a desired therapeutic outcome is achieved in every
      patient, while minimizing patient exposure to both agents.
Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical
      sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek
      treatment (Wed/Thu) to measure:

      Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte
      Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin
      Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum
      Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor

      Weekly ESA and Iron dose delivered will also be recorded.

      From these data:

        1. a mathematical model will be established to find biomarkers most descriptive with
           respect to erythropoiesis-iron synergy,

        2. a mathematical model will be established to correlate iron dose with iron markers.
observational model: Cohort
time perspective: Prospective
measure: Hemoglobin Concentration (g/dL)
time frame: 52 weeks
description: Weekly Hemoglobin Concentration
measure: Transferrin Saturation (%)
time frame: 52 weeks
description: Weekly Transferrin Saturation
measure: Serum Ferritin (ng/mL)
time frame: 52 weeks
description: Weekly Serum Ferritin
arm group label: UofL Subjects
description: Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
arm group label: Duke Subjects
description: Subjects undergoing Specimen Collection at Duke University, Durham, NC
arm group label: WNERTA Subjects
description: Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
intervention type: Other
intervention name: Specimen collection
description: At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.
arm group label: Duke Subjects
arm group label: UofL Subjects
arm group label: WNERTA Subjects
Blood, serum will be extracted and frozen for further analysis. Serum will be retained for up
      to 60 days.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam E Gaweda, Ph.D.
role: Principal Investigator
affiliation: University of Louisville
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Adam Edward Gaweda
investigator title: Associate Professor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Anemia
sharing ipd: Undecided