<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/NCT03824587</url>
  </required_header>
  <id_info>
    <org_study_id>TEN-02-202</org_study_id>
    <nct_id>NCT03824587</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ardelyx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ardelyx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled study to evaluate the effect of&#xD;
      tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28&#xD;
      days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4&#xD;
      weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind&#xD;
      Treatment Period.&#xD;
&#xD;
      At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum&#xD;
      phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be&#xD;
      measured at each visit during the run-in period to enable the evaluation of the s-P&#xD;
      randomization criteria.&#xD;
&#xD;
      Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive&#xD;
      tenapanor or placebo while continuing their existing phosphate binder treatment.&#xD;
&#xD;
      During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting&#xD;
      at a dose of 30 mg bid&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</primary_completion_date>
  <phase>Phase 2/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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.</measure>
    <time_frame>4 Weeks (28 days randomization period; from baseline to week 4)</time_frame>
    <description>Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>s-P Response at Week 4</measure>
    <time_frame>4 Weeks (28 days randomization period)</time_frame>
    <description>Achieving an s-P level &lt;5.5 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Change From Baseline in iFGF23 at Week 4</measure>
    <time_frame>4 Weeks (28 days randomization period)</time_frame>
    <description>iFGF23 at Week 4/baseline iFGF23 - 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Change From Baseline in cFGF23 at Week 4</measure>
    <time_frame>4 Weeks (28 days randomization period)</time_frame>
    <description>cFGF23 at Week 4/baseline cFGF23 - 1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>Tenapanor 30 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>same size, weight and appearance of experimental drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenapanor</intervention_name>
    <description>Active Drug</description>
    <arm_group_label>Tenapanor 30 mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inactive Drug</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phosphate Binder Agents</intervention_name>
    <description>standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tenapanor 30 mg BID</arm_group_label>
    <other_name>sevelamer carbonate</other_name>
    <other_name>ferric citrate</other_name>
    <other_name>calcium carbonate</other_name>
    <other_name>calcium acetate</other_name>
    <other_name>sucroferric oxyhydroxide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent prior to any study specific procedures.&#xD;
&#xD;
          -  Males or females aged 18 to 80 years, inclusive, at Screening&#xD;
&#xD;
          -  Females must be non-pregnant, non-lactating and either be post-menopausal for at least&#xD;
             -2 months, have documentation of irreversible surgical sterilization, use of&#xD;
             acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner&#xD;
             from Screening -until 30 days after the last subject visit.&#xD;
&#xD;
          -  Males must agree to avoid fathering a child (or donating sperm), and therefore be&#xD;
             either sterile (documented) or agree to use approved methods of contraception, from&#xD;
             the time of enrollment until 30 days after end of study.&#xD;
&#xD;
          -  Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic&#xD;
             maintenance peritoneal dialysis (PD) for a minimum of 6 months.&#xD;
&#xD;
          -  If receiving active vitamin D or calcimimetics, the dose should have been unchanged&#xD;
             for the last 4 weeks prior to Screening.&#xD;
&#xD;
          -  Kt/V ≥1.2 at most recent measurement prior to Screening.&#xD;
&#xD;
          -  Prescribed and taking phosphate binder medication at least 3 times per day, and the&#xD;
             prescribed dose should have been unchanged during the last 4 weeks prior to Screening.&#xD;
&#xD;
          -  Serum phosphorus levels must be ≥5.5 and ≤10.0 mg/dL at Screening and the end of the&#xD;
             run-in period, analyzed at the central laboratory used in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hyperphosphatemia defined as having an s-P level &gt;10.0 mg/dL on&#xD;
             phosphate-binders at any time point during routine clinical monitoring for the 3&#xD;
             preceding months before Screening.&#xD;
&#xD;
          -  Serum/plasma parathyroid hormone &gt;1200 pg/mL.&#xD;
&#xD;
          -  Clinical signs of hypovolemia at Screening as judged by the Investigator.&#xD;
&#xD;
          -  History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea&#xD;
             (IBS-D).&#xD;
&#xD;
          -  Scheduled for living donor kidney transplant or plans to relocate to another center&#xD;
             during the study period.&#xD;
&#xD;
          -  Use of an investigational agent within 30 days prior to Screening.&#xD;
&#xD;
          -  Involvement in the planning and/or conduct of the study (applies to both&#xD;
             Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site).&#xD;
&#xD;
          -  If, in the opinion of the Investigator, the subject is unable or unwilling to fulfill&#xD;
             the requirements of the protocol or has a condition which would render the results&#xD;
             uninterpretable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David P Rosenbaum, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Ardelyx</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nephrology Consultants, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Renal Care Pine Bluff</name>
      <address>
        <city>Pine Bluff</city>
        <state>Arkansas</state>
        <zip>71603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Renal Research</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research - Chula Vista</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North America Research Institute</name>
      <address>
        <city>Lynwood</city>
        <state>California</state>
        <zip>90262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Clinical Research - Santa Fe Spring</name>
      <address>
        <city>Montebello</city>
        <state>California</state>
        <zip>90640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Coast Nephrology</name>
      <address>
        <city>Salinas</city>
        <state>California</state>
        <zip>93901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North America Research Institute - San Dimas</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chabot Nephrology Medical Group</name>
      <address>
        <city>Union City</city>
        <state>California</state>
        <zip>94587</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Institute of Research</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Clinical Research, LLC</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Research Group - Coral Gables</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Institute</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Research Group, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Consultants, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Clinical Trials</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Clinic, Inc - Albany GA</name>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <zip>31701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boise Kidney &amp; Hypertension, PLLC - Meridian</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates of Baton Rouge</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Clinic, Inc - Boston/Somerville</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paragon Health PC - Nephrology Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>InterMed Consultants</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology and Hypertension Associates, LTD</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consultants, LLC</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Clinic, Inc - Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polack Renal, LLC (SMO)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kidney Specialists of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Nevada Nephrology Consultants</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Clinic, Inc - North Brunswick</name>
      <address>
        <city>North Brunswick</city>
        <state>New Jersey</state>
        <zip>08902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Medicine Associates</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.S. Renal Care - Gallup</name>
      <address>
        <city>Gallup</city>
        <state>New Mexico</state>
        <zip>87301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney and Hypertension Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney &amp; Hypertension Associates, P.A.</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham Nephrology Associates</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Nephrology Associates - Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati (UC) - Department of Nephrology</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Clinical Research Center</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Nephrology Associates, P.A.</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Nephrology &amp; Hypertension Center Inc.</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCI - Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knoxville Kidney Center, PLLC</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Center Dialysis</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Renal Care - Waxahachie</name>
      <address>
        <city>Mansfield</city>
        <state>Texas</state>
        <zip>76063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Renal Care - Mesquite</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Advancement Center, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Renal Care - Pleasanton Road</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Renal Care - Westover Hills</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</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 31, 2019</study_first_posted>
  <results_first_submitted>December 7, 2022</results_first_submitted>
  <results_first_submitted_qc>February 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2023</results_first_posted>
  <disposition_first_submitted>August 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>February 3, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 6, 2023</disposition_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</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>Hyperphosphatemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Sevelamer</mesh_term>
    <mesh_term>Calcium acetate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03824587/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tenapanor 30 mg BID</title>
          <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run-in Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">No subjects were on treatment during this period</participants>
                <participants group_id="P2" count="511"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">No subjects were on treatment during this period</participants>
                <participants group_id="P2" count="236"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="275"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="275"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney Transplant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tenapanor 30 mg BID</title>
          <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="117"/>
            <count group_id="B2" value="119"/>
            <count group_id="B3" value="236"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.10" spread="12.326"/>
                    <measurement group_id="B2" value="53.88" spread="12.673"/>
                    <measurement group_id="B3" value="54.49" spread="12.491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Phosphorus &lt; 7.5 mg/dL</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Phosphorus &gt;= 7.5 mg/d:</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sevelamer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-Sevelamer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.</title>
        <description>Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.</description>
        <time_frame>4 Weeks (28 days randomization period; from baseline to week 4)</time_frame>
        <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tenapanor 30 mg BID</title>
            <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.</title>
          <description>Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.</description>
          <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.84" spread="0.131"/>
                    <measurement group_id="O2" value="-0.19" spread="0.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.182</dispersion_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.13</ci_lower_limit>
            <ci_upper_limit>-0.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>s-P Response at Week 4</title>
        <description>Achieving an s-P level &lt;5.5 mg/dL</description>
        <time_frame>4 Weeks (28 days randomization period)</time_frame>
        <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tenapanor 30 mg BID</title>
            <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
        </group_list>
        <measure>
          <title>s-P Response at Week 4</title>
          <description>Achieving an s-P level &lt;5.5 mg/dL</description>
          <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0097</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Change From Baseline in iFGF23 at Week 4</title>
        <description>iFGF23 at Week 4/baseline iFGF23 - 1</description>
        <time_frame>4 Weeks (28 days randomization period)</time_frame>
        <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tenapanor 30 mg BID</title>
            <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change From Baseline in iFGF23 at Week 4</title>
          <description>iFGF23 at Week 4/baseline iFGF23 - 1</description>
          <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
          <units>pg/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.756" lower_limit="0.686" upper_limit="0.834"/>
                    <measurement group_id="O2" value="0.931" lower_limit="0.845" upper_limit="1.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0027</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Change From Baseline in cFGF23 at Week 4</title>
        <description>cFGF23 at Week 4/baseline cFGF23 - 1</description>
        <time_frame>4 Weeks (28 days randomization period)</time_frame>
        <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Tenapanor 30 mg BID</title>
            <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change From Baseline in cFGF23 at Week 4</title>
          <description>cFGF23 at Week 4/baseline cFGF23 - 1</description>
          <population>One patient did not receive study drug so was therefore not included in the modified ITT analysis</population>
          <units>pg/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.779" lower_limit="0.716" upper_limit="0.848"/>
                    <measurement group_id="O2" value="0.947" lower_limit="0.871" upper_limit="1.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the 4 week (28 days) treatment period.</time_frame>
      <desc>Adverse events were NOT collected during the run-in period since patients were receiving standard of care; any changes to health status during bhis period were reported in the medical history prior to randomization.&#xD;
The safety analysis includes all patients randomized (whether they received study drug or not).</desc>
      <group_list>
        <group group_id="E1">
          <title>Tenapanor 30 mg BID</title>
          <description>During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).&#xD;
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.&#xD;
Tenapanor: Active Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>same size, weight and appearance of experimental drug&#xD;
Placebo: Inactive Drug&#xD;
Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiorespiratory Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Nodal Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Pulmonary Edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Development Officer</name_or_title>
      <organization>Ardelyx</organization>
      <phone>6175134929</phone>
      <email>drosenbaum@ardelyx.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03824587
org study id: TEN-02-202
nct id: NCT03824587
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of
      tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28
      days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder
      therapy.
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4
      weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind
      Treatment Period.

      At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum
      phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be
      measured at each visit during the run-in period to enable the evaluation of the s-P
      randomization criteria.

      Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive
      tenapanor or placebo while continuing their existing phosphate binder treatment.

      During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting
      at a dose of 30 mg bid
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
time frame: 4 Weeks (28 days randomization period; from baseline to week 4)
description: Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
measure: s-P Response at Week 4
time frame: 4 Weeks (28 days randomization period)
description: Achieving an s-P level <5.5 mg/dL
measure: Relative Change From Baseline in iFGF23 at Week 4
time frame: 4 Weeks (28 days randomization period)
description: iFGF23 at Week 4/baseline iFGF23 - 1
measure: Relative Change From Baseline in cFGF23 at Week 4
time frame: 4 Weeks (28 days randomization period)
description: cFGF23 at Week 4/baseline cFGF23 - 1
arm group label: Tenapanor 30 mg BID
arm group type: Experimental
description: During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.
arm group label: Placebo
arm group type: Placebo Comparator
description: same size, weight and appearance of experimental drug
intervention type: Drug
intervention name: Tenapanor
description: Active Drug
arm group label: Tenapanor 30 mg BID
intervention type: Drug
intervention name: Placebo
description: Inactive Drug
arm group label: Placebo
intervention type: Drug
intervention name: Phosphate Binder Agents
description: standard of care phosphate binder use at study entry was maintained throughout the entire study
arm group label: Placebo
arm group label: Tenapanor 30 mg BID
other name: sevelamer carbonate
other name: ferric citrate
other name: calcium carbonate
other name: calcium acetate
other name: sucroferric oxyhydroxide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: David P Rosenbaum, PhD
role: Study Chair
affiliation: Ardelyx
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country: United States
responsible party type: Sponsor
mesh term: Hyperphosphatemia
mesh term: Calcium, Dietary
mesh term: Calcium Carbonate
mesh term: Calcium
mesh term: Sevelamer
mesh term: Calcium acetate
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