<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/NCT03802617</url>
  </required_header>
  <id_info>
    <org_study_id>MR13A9-4</org_study_id>
    <nct_id>NCT03802617</nct_id>
  </id_info>
  <brief_title>A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.</brief_title>
  <official_title>A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kissei Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maruishi Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kissei Pharmaceutical 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>
      Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety,&#xD;
      efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">October 22, 2019</completion_date>
  <primary_completion_date type="Actual">October 22, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Numerical Rating Scale (NRS) score of itch</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change from baseline in average NRS score of itch at week 8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in itching scores of Shiratori severity criteria</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change from baseline in average itching scores of Shiratori severity criteria at week 8</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">247</enrollment>
  <condition>Uremic Pruritus</condition>
  <arm_group>
    <arm_group_label>MR13A9 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MR13A9 medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MR13A9 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MR13A9</intervention_name>
    <description>Intravenous administration</description>
    <arm_group_label>MR13A9 high dose</arm_group_label>
    <arm_group_label>MR13A9 low dose</arm_group_label>
    <arm_group_label>MR13A9 medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese with male or female aged ≥ 20&#xD;
&#xD;
          -  Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week&#xD;
&#xD;
          -  Patient receiving treatment for itch&#xD;
&#xD;
          -  Patient has a baseline NRS score &gt; 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has pruritus cause other than CKD or its complications&#xD;
&#xD;
          -  Patients has hepatic cirrhosis&#xD;
&#xD;
          -  Patient has a known history of allergic reaction to opiates&#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>Naomi Koshihara</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Development Div.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Multiple Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</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>Pruritus</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/NCT03802617
org study id: MR13A9-4
nct id: NCT03802617
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety,
      efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Numerical Rating Scale (NRS) score of itch
time frame: 8 weeks
description: Change from baseline in average NRS score of itch at week 8
measure: Change in itching scores of Shiratori severity criteria
time frame: 8 weeks
description: Change from baseline in average itching scores of Shiratori severity criteria at week 8
arm group label: MR13A9 low dose
arm group type: Experimental
arm group label: MR13A9 medium dose
arm group type: Experimental
arm group label: MR13A9 high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: MR13A9
description: Intravenous administration
arm group label: MR13A9 high dose
arm group label: MR13A9 low dose
arm group label: MR13A9 medium dose
intervention type: Drug
intervention name: Placebo
description: Intravenous administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Naomi Koshihara
role: Study Director
affiliation: Clinical Development Div.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Pruritus