<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/NCT02988973</url>
  </required_header>
  <id_info>
    <org_study_id>1517-CL-0310</org_study_id>
    <nct_id>NCT02988973</nct_id>
  </id_info>
  <brief_title>A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia</brief_title>
  <official_title>A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FibroGen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted&#xD;
      from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in&#xD;
      the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled&#xD;
      cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted&#xD;
      from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term&#xD;
      treatment of ASP1517 (52 weeks).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of the following three cohorts. Cohort 1; subjects converted from rHuEPO&#xD;
      or DA to ASP1517, Cohort 2; subjects converted from rHuEPO or DA to DA, Cohort 3; subjects&#xD;
      converted from epoetin beta pegol (CERA) to ASP1517. In Cohort 1 and 3, ASP1517 will be&#xD;
      administered orally for 52 weeks. In Cohort 2, DA will be administered subcutaneously for 24&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">September 13, 2019</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>Change from baseline in the average Hemoglobin (Hb)</measure>
    <time_frame>Baseline and Weeks 18 to 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Hb from Week 18 to Week 24</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24</measure>
    <time_frame>Weeks 18 to 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who achieve the target Hb level at each week</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hb to each post-dosing time point</measure>
    <time_frame>Baseline and Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of time points that achieve the target Hb level from Weeks 18 to 24</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment</measure>
    <time_frame>Up to Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by SF-36</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by EQ-5D-5L</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>EQ-5D: EuroQol 5 Dimension 5 Levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by WPAI:ANS</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by FACT-An</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>FACT-An: Functional Assessment of Cancer Therapy-Anemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Hb from weeks 44 to 52</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the average Hb from weeks 44 to 52</measure>
    <time_frame>Baseline and Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52</measure>
    <time_frame>Weeks 44 to 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who achieve the target Hb level at each week</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of time points that achieve the target Hb level from Weeks 44 to 52</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Hematocrit Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Reticulocyte Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Ferrum Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Ferritin Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Transferrin Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Total Iron Binding Capacity Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Soluble Transferrin Receptor Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Soluble Transferrin Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Reticulocyte Hemoglobin Content Level</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Occurence of Hospitalizations</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization</measure>
    <time_frame>Up to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal Vital signs and/or adverse events related to treatment</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by body weight</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by incidence of adverse events</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by standard 12-lead electrocardiogram</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by ophthalmological examination: Fundoscopy</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by ophthalmological examination: optical coherence tomography</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by ophthalmological examination: visual acuity</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal Laboratory values and/or adverse events related to treatment</measure>
    <time_frame>Up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of unchanged ASP1517</measure>
    <time_frame>Up to Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">334</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>rHuEPO or DA to ASP1517</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive roxadustat according to the prior randomization treatment, with starting doses of 70mg thrice weekly (TIW) to participants on &lt;4500 IU/week of rHuEPO or &lt;20 microgram (μg)/week of darbepoetin alfa (DA) and 100mg TIW to participants on ≥4500 IU/week rHuEPO or ≥ 20 μg/week DA. Participants roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rHuEPO or DA to DA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive DA according to the prior randomization treatment, with starting doses of 15 μg/2weeks to participants on ≤ 1500 IU/week of rHuEPO or &lt;11.25 microgram (μg)/week of DA, 30μg/2weeks to participants on &gt;1500 to &lt;6000 IU/week of rHuEPO or ≥ 11.25 to &lt; 22.5 μg/week of DA, 60μg/2weeks to participants on ≥ 6000 IU/week of rHuEPO or ≥ 22.5 to &lt; 37.5 μg/week of DA, 90μg/2weeks to participants on ≥ 37.5 to &lt; 52.5 μg/week of DA, 120μg/2weeks to participants on ≥ 52.5 to &lt; 75 μg/week of DA, 180μg/2weeks to participants on ≥ 75 μg/week of DA. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 15, 30, 60, 90, 120, and 180 μg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epoetin beta pegol to ASP1517</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive roxadustat according to the prior registration treatment, with starting doses of 70mg thrice weekly (TIW) to participants on ≤100 μg/week of Epoetin beta pegol and 100mg TIW to participants on &gt;100 μg/week of Epoetin beta pegol. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>roxadustat</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>Epoetin beta pegol to ASP1517</arm_group_label>
    <arm_group_label>rHuEPO or DA to ASP1517</arm_group_label>
    <other_name>ASP1517</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA</intervention_name>
    <description>Subcutaneous administration</description>
    <arm_group_label>rHuEPO or DA to DA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who were diagnosed with non-dialysis Chronic Kidney Disease and who are&#xD;
             considered not to require renal replacement therapy during the study period&#xD;
&#xD;
          -  Subjects with renal anemia who have been receiving erythropoiesis stimulating agent&#xD;
             (ESA) by subcutaneous injection and whose Hb values are considered stable.&#xD;
&#xD;
          -  Mean of the subject's two most recent Hb values before randomization during the&#xD;
             Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL&#xD;
&#xD;
          -  Either transferrin saturation ≥ 20% or serum ferritin ≥ 100 ng/mL&#xD;
&#xD;
          -  Female subject must either:&#xD;
&#xD;
        Be of non-childbearing potential:&#xD;
&#xD;
          -  post-menopausal, or&#xD;
&#xD;
          -  documented surgically sterile Or, if of childbearing potential,&#xD;
&#xD;
          -  Agree not to try to become pregnant during the study and for 28 days after the final&#xD;
             study drug administration&#xD;
&#xD;
          -  And have a negative urine pregnancy test at pre-screening&#xD;
&#xD;
          -  And, if heterosexually active, agree to consistently use two forms of highly effective&#xD;
             birth control* (at least one of which must be a barrier method) starting at&#xD;
             pre-screening and throughout the study period and continued for 28 days after the&#xD;
             final study drug administration.&#xD;
&#xD;
               -  Female subject must agree not to breastfeed starting at pre-screening and&#xD;
                  throughout the study period, and continued for 28 days after the final study drug&#xD;
                  administration.&#xD;
&#xD;
               -  Female subject must not donate ova starting at pre-screening and throughout the&#xD;
                  study period, and continued for 28 days after the final study drug&#xD;
                  administration.&#xD;
&#xD;
               -  Male subject and their female spouse/partners who are of childbearing potential&#xD;
                  must be using two forms of highly effective birth control (at least one of which&#xD;
                  must be a barrier method) starting at pre-screening and continue throughout the&#xD;
                  study period, and for 12 weeks after the final study drug administration&#xD;
&#xD;
               -  Male subject must not donate sperm starting at pre-screening and throughout the&#xD;
                  study period and, for 12 weeks after the final study drug administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent retinal neovascular lesion untreated or macular edema untreated, and&#xD;
             patients with any condition that significantly compromises the ability to visualize&#xD;
             the retina&#xD;
&#xD;
          -  Concurrent autoimmune disease with inflammation that could impact erythropoiesis&#xD;
&#xD;
          -  History of gastric/intestinal resection considered influential on the absorption of&#xD;
             drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps)&#xD;
             or concurrent gastro-paresis&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Concurrent congestive heart failure (NYHA Class III or higher)&#xD;
&#xD;
          -  History of hospitalization for treatment of stroke, myocardial infarction, or&#xD;
             pulmonary embolism within 12 weeks before the pre-screening assessment&#xD;
&#xD;
          -  Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV)&#xD;
             antibody at the pre-screening assessment, or positive for human immunodeficiency virus&#xD;
             (HIV) in a past test&#xD;
&#xD;
          -  Concurrent other form of anemia than renal anemia&#xD;
&#xD;
          -  History of pure red cell aplasia&#xD;
&#xD;
          -  Having received treatment with protein anabolic hormone, testosterone enanthate, or&#xD;
             mepitiostane within 6 weeks before the pre-screening assessment&#xD;
&#xD;
          -  Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin&#xD;
             that is greater than the criteria, or previous or concurrent another serious liver&#xD;
             disease at pre-screening assessment&#xD;
&#xD;
          -  Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)&#xD;
&#xD;
          -  Having undergone red blood transfusion and/or a surgical procedure consider to promote&#xD;
             anemia and/or ophthalmological surgery within 4 weeks before the pre-screening&#xD;
             assessment&#xD;
&#xD;
          -  Having undergone a kidney transplantation&#xD;
&#xD;
          -  History of serious drug allergy including anaphylactic shock&#xD;
&#xD;
          -  Having a previous history of treatment with ASP1517 or participation in this study&#xD;
&#xD;
          -  Participation in another clinical study or post-marketing clinical study (including&#xD;
             that of a medical device) within 12 weeks before informed consent acquisition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site JP00009</name>
      <address>
        <city>Kasugai</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00030</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00051</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00021</name>
      <address>
        <city>Toyohashi</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00003</name>
      <address>
        <city>Sakura</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00038</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00044</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00008</name>
      <address>
        <city>Kitakyusyu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00013</name>
      <address>
        <city>Kitakyusyu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00040</name>
      <address>
        <city>Kitakyusyu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00057</name>
      <address>
        <city>Kitakyusyu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00042</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00041</name>
      <address>
        <city>Tajimi</city>
        <state>Gifu</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00002</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00037</name>
      <address>
        <city>Hatsukaichi</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00050</name>
      <address>
        <city>Kure</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00049</name>
      <address>
        <city>Aasahikawa</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00007</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00064</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00022</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00066</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00052</name>
      <address>
        <city>Hitachi</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00017</name>
      <address>
        <city>Kasama</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00028</name>
      <address>
        <city>Koga</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00053</name>
      <address>
        <city>Naka</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00023</name>
      <address>
        <city>Sashima-gun</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00019</name>
      <address>
        <city>Toride</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00046</name>
      <address>
        <city>Tsuchiura</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00035</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00031</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00047</name>
      <address>
        <city>Fujisawa</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00001</name>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00016</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00048</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00012</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00036</name>
      <address>
        <city>Ueda</city>
        <state>Nagano</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00059</name>
      <address>
        <city>Higashiosaka</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00005</name>
      <address>
        <city>Izumisano</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00011</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00069</name>
      <address>
        <city>Yao</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00029</name>
      <address>
        <city>Ageo</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00004</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00020</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00025</name>
      <address>
        <city>Adachi-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00043</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00063</name>
      <address>
        <city>Chiyoda-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00067</name>
      <address>
        <city>Hino</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00015</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00024</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00006</name>
      <address>
        <city>Musashino</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00060</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00062</name>
      <address>
        <city>Tachikawa</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00014</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00033</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00065</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00032</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00039</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00045</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00018</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00068</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00026</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00034</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00055</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00056</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00061</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00010</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=398</url>
    <description>Link to results on the Astellas Clinical Study.</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Roxadustat</keyword>
  <keyword>Anemia</keyword>
  <keyword>Non-dialysis chronic kidney disease</keyword>
  <keyword>ASP1517</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT02988973
org study id: 1517-CL-0310
nct id: NCT02988973
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted
      from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in
      the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled
      cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted
      from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term
      treatment of ASP1517 (52 weeks).
This study consists of the following three cohorts. Cohort 1; subjects converted from rHuEPO
      or DA to ASP1517, Cohort 2; subjects converted from rHuEPO or DA to DA, Cohort 3; subjects
      converted from epoetin beta pegol (CERA) to ASP1517. In Cohort 1 and 3, ASP1517 will be
      administered orally for 52 weeks. In Cohort 2, DA will be administered subcutaneously for 24
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in the average Hemoglobin (Hb)
time frame: Baseline and Weeks 18 to 24
measure: Average Hb from Week 18 to Week 24
time frame: Up to Week 24
measure: Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24
time frame: Weeks 18 to 24
measure: Number of participants who achieve the target Hb level at each week
time frame: Up to Week 24
measure: Change from baseline in Hb to each post-dosing time point
time frame: Baseline and Up to Week 52
measure: Proportion of time points that achieve the target Hb level from Weeks 18 to 24
time frame: Up to Week 24
measure: Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment
time frame: Up to Week 4
measure: Quality of life assessed by SF-36
time frame: Up to Week 52
description: SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
measure: Quality of life assessed by EQ-5D-5L
time frame: Up to Week 52
description: EQ-5D: EuroQol 5 Dimension 5 Levels
measure: Quality of life assessed by WPAI:ANS
time frame: Up to Week 52
description: WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms
measure: Quality of life assessed by FACT-An
time frame: Up to Week 52
description: FACT-An: Functional Assessment of Cancer Therapy-Anemia
measure: Average Hb from weeks 44 to 52
time frame: Up to Week 52
measure: Change from baseline in the average Hb from weeks 44 to 52
time frame: Baseline and Up to Week 52
measure: Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52
time frame: Weeks 44 to 52
measure: Number of participants who achieve the target Hb level at each week
time frame: Up to Week 52
measure: Proportion of time points that achieve the target Hb level from Weeks 44 to 52
time frame: Up to Week 52
measure: Average Hematocrit Level
time frame: Up to Week 52
measure: Average Reticulocyte Level
time frame: Up to Week 52
measure: Average Ferrum Level
time frame: Up to Week 52
measure: Average Ferritin Level
time frame: Up to Week 52
measure: Average Transferrin Level
time frame: Up to Week 52
measure: Average Total Iron Binding Capacity Level
time frame: Up to Week 52
measure: Average Soluble Transferrin Receptor Level
time frame: Up to Week 52
measure: Average Soluble Transferrin Level
time frame: Up to Week 52
measure: Average Reticulocyte Hemoglobin Content Level
time frame: Up to Week 52
measure: Number of Occurence of Hospitalizations
time frame: Up to Week 52
measure: Duration of Hospitalization
time frame: Up to week 52
measure: Number of participants with abnormal Vital signs and/or adverse events related to treatment
time frame: Up to Week 52
measure: Safety assessed by body weight
time frame: Up to Week 52
measure: Safety assessed by incidence of adverse events
time frame: Up to Week 52
measure: Safety assessed by standard 12-lead electrocardiogram
time frame: Up to Week 52
measure: Safety assessed by ophthalmological examination: Fundoscopy
time frame: Up to Week 24
measure: Safety assessed by ophthalmological examination: optical coherence tomography
time frame: Up to Week 24
measure: Safety assessed by ophthalmological examination: visual acuity
time frame: Up to Week 24
measure: Number of participants with abnormal Laboratory values and/or adverse events related to treatment
time frame: Up to Week 52
measure: Plasma concentration of unchanged ASP1517
time frame: Up to Week 24
arm group label: rHuEPO or DA to ASP1517
arm group type: Experimental
description: Participants will receive roxadustat according to the prior randomization treatment, with starting doses of 70mg thrice weekly (TIW) to participants on <4500 IU/week of rHuEPO or <20 microgram (μg)/week of darbepoetin alfa (DA) and 100mg TIW to participants on ≥4500 IU/week rHuEPO or ≥ 20 μg/week DA. Participants roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
arm group label: rHuEPO or DA to DA
arm group type: Experimental
description: Participants will receive DA according to the prior randomization treatment, with starting doses of 15 μg/2weeks to participants on ≤ 1500 IU/week of rHuEPO or <11.25 microgram (μg)/week of DA, 30μg/2weeks to participants on >1500 to <6000 IU/week of rHuEPO or ≥ 11.25 to < 22.5 μg/week of DA, 60μg/2weeks to participants on ≥ 6000 IU/week of rHuEPO or ≥ 22.5 to < 37.5 μg/week of DA, 90μg/2weeks to participants on ≥ 37.5 to < 52.5 μg/week of DA, 120μg/2weeks to participants on ≥ 52.5 to < 75 μg/week of DA, 180μg/2weeks to participants on ≥ 75 μg/week of DA. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 15, 30, 60, 90, 120, and 180 μg.
arm group label: Epoetin beta pegol to ASP1517
arm group type: Experimental
description: Participants will receive roxadustat according to the prior registration treatment, with starting doses of 70mg thrice weekly (TIW) to participants on ≤100 μg/week of Epoetin beta pegol and 100mg TIW to participants on >100 μg/week of Epoetin beta pegol. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
intervention type: Drug
intervention name: roxadustat
description: Oral administration
arm group label: Epoetin beta pegol to ASP1517
arm group label: rHuEPO or DA to ASP1517
other name: ASP1517
intervention type: Drug
intervention name: DA
description: Subcutaneous administration
arm group label: rHuEPO or DA to DA
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
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country: Japan
url: https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=398
description: Link to results on the Astellas Clinical Study.
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."