<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/NCT03799926</url>
  </required_header>
  <id_info>
    <org_study_id>ZG-801-01</org_study_id>
    <nct_id>NCT03799926</nct_id>
  </id_info>
  <brief_title>Exploratory Study of ZG-801 for the Treatment of Hyperkalemia</brief_title>
  <official_title>ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeria Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeria Pharmaceutical</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 investigate the efficacy of each ZG-801 starting dose and the titration algorithm of&#xD;
      ZG-801 for the treatment of hyperkalemia in Japanese patients.&#xD;
&#xD;
      To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to&#xD;
      confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 6, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose</measure>
    <time_frame>Baseline to week 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum potassium 4 weeks after the start of administration in each group of starting dose</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Over 52-week study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse drug reactions</measure>
    <time_frame>Over 52-week study period</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Hyperkalemia</condition>
  <arm_group>
    <arm_group_label>Stratum 1: 8.4 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 5.1 to &lt; 6.0 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 1: 16.8 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 5.1 to &lt; 6.0 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 1: placebo of 8.4 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 5.1 to &lt; 6.0 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 1: placebo of 16.8 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 5.1 to &lt; 6.0 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 2: 8.4 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 6.0 to &lt; 6.5 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 2: 16.8 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-dialysis subjects with serum potassium 6.0 to &lt; 6.5 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 3: 8.4 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dialysis subjects with serum potassium 5.5 to &lt; 6.5 mEq/L range at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stratum 3: 16.8 g patiromer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dialysis subjects with serum potassium 5.5 to &lt; 6.5 mEq/L range at baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)</description>
    <arm_group_label>Stratum 1: 8.4 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)</description>
    <arm_group_label>Stratum 1: 16.8 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)</description>
    <arm_group_label>Stratum 1: placebo of 8.4 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)</description>
    <arm_group_label>Stratum 1: placebo of 16.8 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)</description>
    <arm_group_label>Stratum 2: 8.4 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)</description>
    <arm_group_label>Stratum 2: 16.8 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)</description>
    <arm_group_label>Stratum 3: 8.4 g patiromer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patiromer</intervention_name>
    <description>Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)</description>
    <arm_group_label>Stratum 3: 16.8 g patiromer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females ages 18 - 80&#xD;
&#xD;
          -  Informed consent given&#xD;
&#xD;
          -  Serum Potassium measurement at baseline is 5.1 to &lt; 6.5 mEq/L (Non-dialysis patients&#xD;
             or 5.5 to &lt; 6.5 mEq/L (Dialysis patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for&#xD;
             acute exacerbations of heart failure within the previous 3 months&#xD;
&#xD;
          -  Subjects with severe heart failure, defined as NYHA (New York Heart Association) class&#xD;
             IV&#xD;
&#xD;
          -  Subjects with uncorrected hemodynamically significant primary vascular disease or&#xD;
             uncontrolled or hemodynamically unstable arrhythmia&#xD;
&#xD;
          -  Subjects with coronary artery bypass graft, percutaneous intervention, or major&#xD;
             surgery including thoracic and cardiac, within the previous 3 months or anticipated&#xD;
             need during study participation&#xD;
&#xD;
          -  Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient,&#xD;
             or anticipated need for transplant during the study period&#xD;
&#xD;
          -  Subjects with any of the significant cardiovascular or cerebrovascular events within&#xD;
             the previous 2 months&#xD;
&#xD;
          -  Subjects with a history of or current diagnosis of a severe swallowing disorder,&#xD;
             moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction&#xD;
             or severe gastrointestinal disorders or major gastrointestinal surgery&#xD;
&#xD;
          -  Subjects who cannot use the oral concomitant medication to be separate 3 hours from&#xD;
             ZG-801 medication&#xD;
&#xD;
          -  Subjects suspected of transient high potassium levels, such as those caused only by&#xD;
             dietary effects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 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>Hyperkalemia</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/NCT03799926
org study id: ZG-801-01
nct id: NCT03799926
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of
      ZG-801 for the treatment of hyperkalemia in Japanese patients.

      To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to
      confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
time frame: Baseline to week 1
measure: Change in serum potassium 4 weeks after the start of administration in each group of starting dose
time frame: Baseline to week 4
measure: Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose
time frame: Week 4
measure: Incidence of adverse events
time frame: Over 52-week study period
measure: Incidence of adverse drug reactions
time frame: Over 52-week study period
arm group label: Stratum 1: 8.4 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
arm group label: Stratum 1: 16.8 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
arm group label: Stratum 1: placebo of 8.4 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
arm group label: Stratum 1: placebo of 16.8 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
arm group label: Stratum 2: 8.4 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
arm group label: Stratum 2: 16.8 g patiromer
arm group type: Experimental
description: Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
arm group label: Stratum 3: 8.4 g patiromer
arm group type: Experimental
description: Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
arm group label: Stratum 3: 16.8 g patiromer
arm group type: Experimental
description: Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
arm group label: Stratum 1: 8.4 g patiromer
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
arm group label: Stratum 1: 16.8 g patiromer
intervention type: Drug
intervention name: placebo
description: Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
arm group label: Stratum 1: placebo of 8.4 g patiromer
intervention type: Drug
intervention name: placebo
description: Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
arm group label: Stratum 1: placebo of 16.8 g patiromer
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
arm group label: Stratum 2: 8.4 g patiromer
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
arm group label: Stratum 2: 16.8 g patiromer
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
arm group label: Stratum 3: 8.4 g patiromer
intervention type: Drug
intervention name: patiromer
description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
arm group label: Stratum 3: 16.8 g patiromer
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hyperkalemia