<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/NCT03831607</url>
  </required_header>
  <id_info>
    <org_study_id>7791-003</org_study_id>
    <nct_id>NCT03831607</nct_id>
  </id_info>
  <brief_title>A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD</brief_title>
  <official_title>A Phase 2, Open-label Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on 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>
    <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 effect and safety of a switch from phosphate binders to KHK7791 to treat&#xD;
      Hyperphosphatemia in patients on HD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">November 26, 2019</completion_date>
  <primary_completion_date type="Actual">November 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.</measure>
    <time_frame>Week 26</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum phosphorus levels at each time point after the start of treatment</measure>
    <time_frame>up to Week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected serum calcium level at each time point after the start of treatment</measure>
    <time_frame>up to Week 26</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>KHK7791</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK7791</intervention_name>
    <description>KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets</description>
    <arm_group_label>KHK7791</arm_group_label>
    <other_name>Tenapanor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable chronic renal failure patients who have undergone hemodialysis 3 times per week&#xD;
             for at least 12 weeks until screening examination.&#xD;
&#xD;
          -  Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer,&#xD;
             Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and&#xD;
             Substitution Fluid Flow Rate) 2 weeks before screening examination.&#xD;
&#xD;
          -  Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage&#xD;
             regimen should have been unchanged for the period from 2 weeks before screening&#xD;
             examination through pre-enrollment.&#xD;
&#xD;
          -  Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening&#xD;
             examination.&#xD;
&#xD;
          -  If on any vitamin D or calcimimetics regimen, the dosage regimen should have been&#xD;
             unchanged for the last 2 weeks before screening examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  iPTH &gt; 600 pg/mL (should be based on the most recent value from patient's medical&#xD;
             records before pre-enrollment)&#xD;
&#xD;
          -  History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel&#xD;
             syndrome&#xD;
&#xD;
          -  History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy)&#xD;
             or having undergone gastrointestinal tract surgery within 3 months before screening&#xD;
             examination.&#xD;
&#xD;
          -  Severe heart disease (including congestive heart failure, defined as New York Heart&#xD;
             Association [NYHA] cardiac functional classification of Class III or IV, and vascular&#xD;
             lesions requiring hospitalization such as myocardial infarction), hepatic impairment&#xD;
             (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent&#xD;
             cirrhosis.&#xD;
&#xD;
          -  Developed cerebrovascular disease (such as cerebral infarction and cerebral&#xD;
             hemorrhage) or cardiovascular disease (such as acute myocardial infarction and&#xD;
             unstable angina) requiring hospitalization within 6 months before screening&#xD;
             examination.&#xD;
&#xD;
          -  Uncontrollable hypertension or diabetes&#xD;
&#xD;
          -  Scheduled for living donor kidney transplant, change in the mode of dialysis, home&#xD;
             hemodialysis or plans to change the dialysis center (relocate to another&#xD;
             hospital/clinic) during the study period.&#xD;
&#xD;
          -  Any diagnosis of or treatment of malignancy within 5 years before screening&#xD;
             examination (excluding basal cell carcinoma or surgically resected intraepithelial&#xD;
             carcinoma of uterine cervix).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 1</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tenapanor</keyword>
  <keyword>Hyperphosphatemia</keyword>
  <keyword>Hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperphosphatemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 6, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03831607
org study id: 7791-003
nct id: NCT03831607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat
      Hyperphosphatemia in patients on HD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.
time frame: Week 26
measure: Serum phosphorus levels at each time point after the start of treatment
time frame: up to Week 26
measure: Corrected serum calcium level at each time point after the start of treatment
time frame: up to Week 26
arm group label: KHK7791
arm group type: Experimental
description: Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question.
intervention type: Drug
intervention name: KHK7791
description: KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets
arm group label: KHK7791
other name: Tenapanor
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hyperphosphatemia
sharing ipd: Undecided
submitted: April 6, 2023