<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/NCT03242967</url>
  </required_header>
  <id_info>
    <org_study_id>AKB-6548-CI-0023</org_study_id>
    <nct_id>NCT03242967</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)</brief_title>
  <acronym>TRILOGY</acronym>
  <official_title>Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akebia Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akebia Therapeutics</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for&#xD;
      Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Revised study design.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Actual">February 12, 2018</completion_date>
  <primary_completion_date type="Actual">February 12, 2018</primary_completion_date>
  <phase>Phase 3</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>Mean change in Hb between baseline and the primary evaluation period</measure>
    <time_frame>Baseline visit, Week 36</time_frame>
    <description>Mean change in hemoglobin will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in Hb between baseline and the secondary evaluation period</measure>
    <time_frame>Baseline visit, Week 52</time_frame>
    <description>Mean change in hemoglobin will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with mean Hb within the target range during the primary evaluation period</measure>
    <time_frame>Baseline visit, Week 36</time_frame>
    <description>Hemoglobin values within the target range will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anemia</condition>
  <condition>Dialysis-Dependent Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Vadadustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subcutaneous or intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vadadustat</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Vadadustat</arm_group_label>
    <other_name>AKB-6548</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin alfa</intervention_name>
    <description>subcutaneous or intravenous</description>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
    <other_name>Aranesp</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥18 years of age&#xD;
&#xD;
          -  Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage&#xD;
             kidney disease&#xD;
&#xD;
          -  Currently maintained on ESA therapy&#xD;
&#xD;
          -  Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia due to a cause other than CKD or presence of active bleeding or recent blood&#xD;
             loss&#xD;
&#xD;
          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic&#xD;
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia&#xD;
&#xD;
          -  Red blood cell transfusion within 4 weeks prior to or during screening&#xD;
&#xD;
          -  Anticipated to recover adequate kidney function to no longer require hemodialysis&#xD;
             during study participation&#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>Akebia Therapeutics</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anemia</keyword>
  <keyword>hemoglobin</keyword>
  <keyword>darbepoetin alfa</keyword>
  <keyword>TIW</keyword>
  <keyword>hypoxia-inducible factor prolyl-hydroxylase inhibitor</keyword>
  <keyword>HIF-PHI</keyword>
  <keyword>AKB-6548</keyword>
  <keyword>vadadustat</keyword>
  <keyword>renal</keyword>
  <keyword>hypoxia-inducible factor</keyword>
  <keyword>HIF</keyword>
  <keyword>dialysis-dependent chronic kidney disease</keyword>
  <keyword>CKD</keyword>
  <keyword>DD-CKD</keyword>
  <keyword>kidney</keyword>
  <keyword>erythropoiesis stimulating agent</keyword>
  <keyword>ESA</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Darbepoetin alfa</mesh_term>
  </intervention_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/NCT03242967
org study id: AKB-6548-CI-0023
nct id: NCT03242967
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for
      Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in Hb between baseline and the primary evaluation period
time frame: Baseline visit, Week 36
description: Mean change in hemoglobin will be evaluated
measure: Mean change in Hb between baseline and the secondary evaluation period
time frame: Baseline visit, Week 52
description: Mean change in hemoglobin will be evaluated
measure: Proportion of subjects with mean Hb within the target range during the primary evaluation period
time frame: Baseline visit, Week 36
description: Hemoglobin values within the target range will be evaluated
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: 52 weeks
description: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated
arm group label: Vadadustat
arm group type: Experimental
description: Oral tablet
arm group label: Darbepoetin alfa
arm group type: Active Comparator
description: subcutaneous or intravenous
intervention type: Drug
intervention name: Vadadustat
description: Oral tablet
arm group label: Vadadustat
other name: AKB-6548
intervention type: Drug
intervention name: Darbepoetin alfa
description: subcutaneous or intravenous
arm group label: Darbepoetin alfa
other name: Aranesp
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Akebia Therapeutics
role: Study Director
affiliation: Sponsor GmbH
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Darbepoetin alfa
sharing ipd: Undecided