<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/NCT02216656</url>
  </required_header>
  <id_info>
    <org_study_id>7580-005</org_study_id>
    <nct_id>NCT02216656</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of KHK7580</brief_title>
  <official_title>A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, placebo-controlled, double-blind (included open arm of KRN1493&#xD;
      (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety&#xD;
      in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for&#xD;
      three weeks for secondary hyperparathyroidism patients receiving hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percent changes in intact Parathyroid hormone levels from baseline</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Percent changes in intact Parathyroid hormone levels from baseline to end of administration period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Number and types of adverse events&#xD;
laboratory tests&#xD;
vital signs&#xD;
12-lead electrocardiogram&#xD;
ophthalmological examination</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Secondary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Plascebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KHK7580 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KHK7580 middle dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KHK7580 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KRN1493</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>Plascebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK7580 low dose</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>KHK7580 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK7580 middle dose</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>KHK7580 middle dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK7580 high dose</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>KHK7580 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KRN1493</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>KRN1493</arm_group_label>
    <other_name>cinacalcet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have voluntarily consented to participate in this study&#xD;
&#xD;
          -  Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for&#xD;
             at least 12 weeks before screening&#xD;
&#xD;
          -  Subjects with an intact Parathyroid hormone of &gt;= 240 pg/mL at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with primary hyperparathyroidism&#xD;
&#xD;
          -  Subjects who have received cinacalcet hydrochloride within 2 weeks before screening&#xD;
&#xD;
          -  Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative,&#xD;
             phosphate binders, or calcium preparation has been changed or started within 2 weeks&#xD;
             before screening.&#xD;
&#xD;
          -  Subjects who have underwent parathyroidectomy and/or parathyroid intervention within&#xD;
             24 weeks before screening.&#xD;
&#xD;
          -  Subjects with uncontrolled hypertension and/or diabetes&#xD;
&#xD;
          -  Subjects with severe heart disease.&#xD;
&#xD;
          -  Subjects with severe hepatic dysfunction.&#xD;
&#xD;
          -  Subjects who have received any other investigational drug within 12 weeks before&#xD;
             screening&#xD;
&#xD;
          -  Other subjects unfit for participation in this study in the judgment of the&#xD;
             investigator or sub investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>July 8, 2018</last_update_submitted>
  <last_update_submitted_qc>July 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2018</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>
  <!-- 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/NCT02216656
org study id: 7580-005
nct id: NCT02216656
lead sponsor: 
has dmc: No
This randomized, placebo-controlled, double-blind (included open arm of KRN1493
      (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety
      in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for
      three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The percent changes in intact Parathyroid hormone levels from baseline
time frame: Up to 3 weeks
description: Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
measure: Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
time frame: Up to 3 weeks
description: Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.
measure: Safety
time frame: Up to 3 weeks
description: Number and types of adverse events
laboratory tests
vital signs
12-lead electrocardiogram
ophthalmological examination
arm group label: Plascebo
arm group type: Placebo Comparator
arm group label: KHK7580 low dose
arm group type: Experimental
arm group label: KHK7580 middle dose
arm group type: Experimental
arm group label: KHK7580 high dose
arm group type: Experimental
arm group label: KRN1493
arm group type: Active Comparator
intervention type: Drug
intervention name: Placebo
description: Oral administration
arm group label: Plascebo
intervention type: Drug
intervention name: KHK7580 low dose
description: Oral administration
arm group label: KHK7580 low dose
intervention type: Drug
intervention name: KHK7580 middle dose
description: Oral administration
arm group label: KHK7580 middle dose
intervention type: Drug
intervention name: KHK7580 high dose
description: Oral administration
arm group label: KHK7580 high dose
intervention type: Drug
intervention name: KRN1493
description: Oral administration
arm group label: KRN1493
other name: cinacalcet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 74 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
mesh term: Cinacalcet