<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/NCT03801980</url>
  </required_header>
  <id_info>
    <org_study_id>AJ1004</org_study_id>
    <nct_id>NCT03801980</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of SK-1403</brief_title>
  <official_title>Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanwa Kagaku Kenkyusho Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanwa Kagaku Kenkyusho Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with&#xD;
      secondary hyperparathyroidism on maintenance hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">December 21, 2019</completion_date>
  <primary_completion_date type="Actual">December 17, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured values and Changes from baseline in serum PTH</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value; unit of measure (pg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured values and Changes from baseline in Ca</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value; unit of measure (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured values and Changes from baseline in ionized Ca</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value; unit of measure (mEq/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured values and Changes from baseline in P</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value; unit of measure (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured values and Changes from baseline in serum Ca x P product</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by laboratory test value</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Secondary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>SK-1403</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SK-1403</intervention_name>
    <description>Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.</description>
    <arm_group_label>SK-1403</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Serum PTH&gt;240 pg/mL at the screening&#xD;
&#xD;
          -  Serum corrected Ca≧8.4 mg/dL at the screening&#xD;
&#xD;
          -  Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis&#xD;
             filtration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary hyperparathyroidism&#xD;
&#xD;
          -  Severe liver disease&#xD;
&#xD;
          -  Severe Cardiac disease&#xD;
&#xD;
          -  History or family history of long QT syndrome&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  History of severe drug allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigational site (there may be other sites in this country)</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</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>
  <!-- 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/NCT03801980
org study id: AJ1004
nct id: NCT03801980
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with
      secondary hyperparathyroidism on maintenance hemodialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
time frame: 24 weeks
description: Assessed by laboratory test value
measure: Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.
time frame: 24 weeks
description: Assessed by laboratory test value
measure: Measured values and Changes from baseline in serum PTH
time frame: 24 weeks
description: Assessed by laboratory test value; unit of measure (pg/mL)
measure: Measured values and Changes from baseline in Ca
time frame: 24 weeks
description: Assessed by laboratory test value; unit of measure (mg/dL)
measure: Measured values and Changes from baseline in ionized Ca
time frame: 24 weeks
description: Assessed by laboratory test value; unit of measure (mEq/dL)
measure: Measured values and Changes from baseline in P
time frame: 24 weeks
description: Assessed by laboratory test value; unit of measure (mg/dL)
measure: Measured values and Changes from baseline in serum Ca x P product
time frame: 24 weeks
description: Assessed by laboratory test value
arm group label: SK-1403
arm group type: Experimental
description: Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
intervention type: Drug
intervention name: SK-1403
description: Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
arm group label: SK-1403
intervention type: Drug
intervention name: Placebo
description: Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary