<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/NCT03018067</url>
  </required_header>
  <id_info>
    <org_study_id>RDX227675-201</org_study_id>
    <nct_id>NCT03018067</nct_id>
  </id_info>
  <brief_title>A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia</brief_title>
  <official_title>A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action,&#xD;
      safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are&#xD;
      randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g&#xD;
      qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free&#xD;
      follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor stopped program]&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exponential Rate of Change in Serum Potassium from Baseline</measure>
    <time_frame>48 hours</time_frame>
    <description>Onset of Action</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Potassium Levels</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hyperkalemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 g qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDX227675, 10 g qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 g qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDX227675, 20 g qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 g qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDX227675, 30 g qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDX227675</intervention_name>
    <arm_group_label>10 g qd</arm_group_label>
    <arm_group_label>20 g qd</arm_group_label>
    <arm_group_label>30 g qd</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 85 years old, inclusive&#xD;
&#xD;
          -  Two consecutive i-STAT K values ≥ 5.5 to &lt; 6.5 mmol/L, measured a minimum of&#xD;
             60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to&#xD;
             randomization)&#xD;
&#xD;
          -  i-STAT K value ≥ 5.5 to &lt; 6.5 mmol/L on Day 1 (prior to randomization)&#xD;
&#xD;
          -  Ability to have repeated blood draws or effective venous catheterization&#xD;
&#xD;
          -  Females of child bearing potential must have negative urine pregnancy test on Day 1&#xD;
             (prior to randomization)&#xD;
&#xD;
          -  Females but be non-pregnant, non-lactating, and either be post-menopausal for at least&#xD;
             12 months, have documentation of irreversible surgical sterilization, or confirm the&#xD;
             use of one of the acceptable contraceptive methods&#xD;
&#xD;
          -  Males must agree to use an appropriate method of contraception or have documented&#xD;
             surgical sterilization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pseudohyperkalemia signs and symptoms&#xD;
&#xD;
          -  Treatment with K lowering drugs, within 7 days prior to randomization&#xD;
&#xD;
          -  Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c &gt; 10%, or&#xD;
             hospitalization to treat hyper- or hypo-glycemia in the past 3 months&#xD;
&#xD;
          -  Diabetic ketoacidosis&#xD;
&#xD;
          -  Known hypersensitivity to polystyrene sulfonate&#xD;
&#xD;
          -  Significant cardiovascular or cerebrovascular events in the past 2 months&#xD;
&#xD;
          -  Severe heart failure, defined as NYHA (New York Heart Association) class IV or&#xD;
             hospitalization to treat heart failure in previous 3 months&#xD;
&#xD;
          -  History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders,&#xD;
             or major gastrointestinal surgery&#xD;
&#xD;
          -  Major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other&#xD;
             psychoses that has required hospitalization in the last 3 years. History of attempted&#xD;
             suicide or uncontrolled bipolar disorder.&#xD;
&#xD;
          -  Use of an investigational product within 30 days prior to Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David P Rosenbaum, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Ardelyx, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Capital Nephrology Associates, PA</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>December 23, 2019</last_update_submitted>
  <last_update_submitted_qc>December 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2019</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03018067
org study id: RDX227675-201
nct id: NCT03018067
lead sponsor: 
has dmc: No
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action,
      safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are
      randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g
      qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).
The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free
      follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Exponential Rate of Change in Serum Potassium from Baseline
time frame: 48 hours
description: Onset of Action
measure: Change in Serum Potassium Levels
time frame: 7 days
measure: Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]
time frame: 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day.
arm group label: 10 g qd
arm group type: Experimental
description: RDX227675, 10 g qd
arm group label: 20 g qd
arm group type: Experimental
description: RDX227675, 20 g qd
arm group label: 30 g qd
arm group type: Experimental
description: RDX227675, 30 g qd
intervention type: Drug
intervention name: RDX227675
arm group label: 10 g qd
arm group label: 20 g qd
arm group label: 30 g qd
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: David P Rosenbaum, Ph.D.
role: Study Chair
affiliation: Ardelyx, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkalemia
sharing ipd: No