<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/NCT03822507</url>
  </required_header>
  <id_info>
    <org_study_id>7580-201</org_study_id>
    <nct_id>NCT03822507</nct_id>
  </id_info>
  <brief_title>Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyowa Kirin China Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyowa Kirin Korea Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyowa Kirin Co., Ltd.</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 purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally&#xD;
      administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active&#xD;
      control in subjects with secondary hyperparathyroidism receiving hemodialysis in China,&#xD;
      Korea, Hong Kong and Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2019</start_date>
  <completion_date type="Actual">September 23, 2021</completion_date>
  <primary_completion_date type="Actual">September 23, 2021</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intact PTH level</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corrected serum Ca level</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum P level</measure>
    <time_frame>Week 50- Week 52</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Secondary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>KHK7580 1mg-12mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cinacalcet 25mg-100mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK7580</intervention_name>
    <description>oral administration</description>
    <arm_group_label>KHK7580 1mg-12mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cinacalcet Hydrochloride</intervention_name>
    <description>oral administration</description>
    <arm_group_label>Cinacalcet 25mg-100mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Personally submitted written voluntary informed consent to participate in the study&#xD;
&#xD;
          2. Aged ≧18 years at the time of consent&#xD;
&#xD;
          3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12&#xD;
             weeks before screening&#xD;
&#xD;
          4. Intact PTH level (centrally measured) of &gt;300 pg/mL at screening&#xD;
&#xD;
          5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with cinacalcet hydrochloride within 2 weeks before screening&#xD;
&#xD;
          2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative,&#xD;
             phosphate binder, or Ca preparation within 2 weeks before screening; or start of&#xD;
             treatment with such drugs within 2 weeks before screening&#xD;
&#xD;
          3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed&#xD;
             dialysis time, and prescribed number of dialysis per week) within 2 weeks before&#xD;
             screening&#xD;
&#xD;
          4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before&#xD;
             screening&#xD;
&#xD;
          5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening&#xD;
&#xD;
          6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)&#xD;
&#xD;
          7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)&#xD;
&#xD;
          8. Uncontrolled hypertension and/or diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research site_29</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_34</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_25</name>
      <address>
        <city>Foshan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_22</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_23</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_30</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_28</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_32</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_33</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_24</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_26</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_27</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_31</name>
      <address>
        <city>Wuxi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_11</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_21</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_13</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_15</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_12</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_18</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_14</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_17</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_19</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_20</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_16</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_2</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_3</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_5</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_9</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_4</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_7</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_10</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_1</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_6</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site_8</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Secondary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cinacalcet</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03822507
org study id: 7580-201
nct id: NCT03822507
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally
      administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active
      control in subjects with secondary hyperparathyroidism receiving hemodialysis in China,
      Korea, Hong Kong and Taiwan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
time frame: Week 50- Week 52
measure: Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
time frame: Week 50- Week 52
measure: Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
time frame: Week 50- Week 52
measure: Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
time frame: Week 50- Week 52
measure: Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
time frame: Week 50- Week 52
measure: Intact PTH level
time frame: Week 50- Week 52
measure: corrected serum Ca level
time frame: Week 50- Week 52
measure: serum P level
time frame: Week 50- Week 52
arm group label: KHK7580 1mg-12mg
arm group type: Experimental
arm group label: Cinacalcet 25mg-100mg
arm group type: Active Comparator
intervention type: Drug
intervention name: KHK7580
description: oral administration
arm group label: KHK7580 1mg-12mg
intervention type: Drug
intervention name: Cinacalcet Hydrochloride
description: oral administration
arm group label: Cinacalcet 25mg-100mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: China
country: Hong Kong
country: Korea, Republic of
country: Taiwan
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
mesh term: Cinacalcet
sharing ipd: No