<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/NCT04443608</url>
  </required_header>
  <id_info>
    <org_study_id>CRA-US-001</org_study_id>
    <nct_id>NCT04443608</nct_id>
  </id_info>
  <brief_title>Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management</brief_title>
  <acronym>PLATINUM</acronym>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 4 Study of the Efficacy &amp; Safety of Patiromer for Oral Suspension in Combination With Standard of Care Treatment in ED Patients With Hyperkalemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comprehensive Research Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Comprehensive Research Associates</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      When a patient arrives to an emergency department and is found to have an elevated potassium&#xD;
      level in the blood, there is no one standardized treatment, therefore it is not known if one&#xD;
      treatment is superior to other. The purpose of this study is to help determine if a drug&#xD;
      called patiromer (already approved by the FDA) can help lower potassium levels while patients&#xD;
      are in the emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of&#xD;
      emergent dialysis, there is a need for the development and systematic evaluation of a&#xD;
      treatment protocol to shift potassium into the cells followed by the removal of potassium&#xD;
      from the body with a potassium binder.. The present study will use a systematic approach to&#xD;
      shifting potassium into the cells followed by binding potassium in the gastrointestinal tract&#xD;
      in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or&#xD;
      placebo to determine if patiromer reduces the need for additional medical intervention for&#xD;
      the management of hyperkalemia in patients initially treated with IV and inhaled therapy in&#xD;
      the ED.&#xD;
&#xD;
      Upon enrollment, patiromer will be administered at a dose selected because of its safety and&#xD;
      efficacy shown in a pilot study named REDUCE.&#xD;
&#xD;
      Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will&#xD;
      be measured at pre-determined intervals to assess drug's impact. concomitant medications will&#xD;
      be recorded to help determine if study drug helped, not just lower hyperkalemia, but also&#xD;
      decrease the number of total interventions needed to reach a normal potassium level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment window ended&#xD;
  </why_stopped>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Actual">June 3, 2023</completion_date>
  <primary_completion_date type="Actual">March 9, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>randomized, double-blinded, placebo-controlled parallel group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The need for additional potassium-lowering medical interventions</measure>
    <time_frame>Duration of patient's emergency department visit, up to 6 hours</time_frame>
    <description>Net clinical benefit (mean difference in number of interventions less change in serum potassium)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Potassium level trends after receiving study drug</measure>
    <time_frame>Up to 24 hours after study drug dose is given</time_frame>
    <description>Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium level trends after receiving study drug</measure>
    <time_frame>4 hours</time_frame>
    <description>Net clinical benefit at Hour 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium level trends after receiving study drug</measure>
    <time_frame>ED visit, up to 10 hours</time_frame>
    <description>Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium level trends after receiving study drug</measure>
    <time_frame>8 hours</time_frame>
    <description>Proportion of subjects with sustained potassium reduction (defined as K+ ≤5.5 mEq/l and 4 hours without potassium-related medical intervention) at Hours 6 and 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium level trends after receiving study drug</measure>
    <time_frame>Up to 24 hours after study drug dose is given</time_frame>
    <description>K+ 24 hours after ED discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Hyperkalemia</condition>
  <arm_group>
    <arm_group_label>Veltassa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patiromer Powder for Oral Suspension [Veltassa]</intervention_name>
    <description>Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink</description>
    <arm_group_label>Veltassa</arm_group_label>
    <other_name>Active drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Inactive substance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care&#xD;
             testing&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV&#xD;
             antiarrhythmic therapy.&#xD;
&#xD;
          2. Patients who are hemodynamically unstable, defined as mean arterial pressure ≤65 mmHg&#xD;
             or heart rate ≤40 beats per minute or ≥125 beats per minute at time of screening&#xD;
&#xD;
          3. Hyperkalemia solely due to overdose on potassium supplements&#xD;
&#xD;
          4. Known bowel obstruction&#xD;
&#xD;
          5. Subjects currently being treated with or having taken potassium binders (e.g.,&#xD;
             patiromer, sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate)&#xD;
             in the 7 days prior to baseline&#xD;
&#xD;
          6. Subjects expected to receive dialysis during the first 6 hours of the study treatment&#xD;
             period&#xD;
&#xD;
          7. Known hypersensitivity to patiromer or its ingredients&#xD;
&#xD;
          8. Participation in any other investigational device or drug study &lt;30 days prior to&#xD;
             screening, or current treatment with other investigational agent(s)&#xD;
&#xD;
          9. Inability to consume the investigational product or, in the opinion of the&#xD;
             Investigator unsuitable for study participation&#xD;
&#xD;
         10. Life expectancy of less than 6 months&#xD;
&#xD;
         11. Patients with automatically timed medication orders to control potassium in the ED&#xD;
&#xD;
         12. Patient is known to be pregnant or breastfeeding&#xD;
&#xD;
         13. An employee of investigational site or sponsors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin Healthcare Research Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University of St Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt Sinai. Icahn School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University. Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JPS Health Network</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>potassium</keyword>
  <keyword>dialysis</keyword>
  <keyword>emergency department</keyword>
  <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/NCT04443608
org study id: CRA-US-001
nct id: NCT04443608
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
When a patient arrives to an emergency department and is found to have an elevated potassium
      level in the blood, there is no one standardized treatment, therefore it is not known if one
      treatment is superior to other. The purpose of this study is to help determine if a drug
      called patiromer (already approved by the FDA) can help lower potassium levels while patients
      are in the emergency department.
Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of
      emergent dialysis, there is a need for the development and systematic evaluation of a
      treatment protocol to shift potassium into the cells followed by the removal of potassium
      from the body with a potassium binder.. The present study will use a systematic approach to
      shifting potassium into the cells followed by binding potassium in the gastrointestinal tract
      in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or
      placebo to determine if patiromer reduces the need for additional medical intervention for
      the management of hyperkalemia in patients initially treated with IV and inhaled therapy in
      the ED.

      Upon enrollment, patiromer will be administered at a dose selected because of its safety and
      efficacy shown in a pilot study named REDUCE.

      Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will
      be measured at pre-determined intervals to assess drug's impact. concomitant medications will
      be recorded to help determine if study drug helped, not just lower hyperkalemia, but also
      decrease the number of total interventions needed to reach a normal potassium level.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, double-blinded, placebo-controlled parallel group
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The need for additional potassium-lowering medical interventions
time frame: Duration of patient's emergency department visit, up to 6 hours
description: Net clinical benefit (mean difference in number of interventions less change in serum potassium)
measure: Potassium level trends after receiving study drug
time frame: Up to 24 hours after study drug dose is given
description: Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8
measure: Potassium level trends after receiving study drug
time frame: 4 hours
description: Net clinical benefit at Hour 4
measure: Potassium level trends after receiving study drug
time frame: ED visit, up to 10 hours
description: Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge
measure: Potassium level trends after receiving study drug
time frame: 8 hours
description: Proportion of subjects with sustained potassium reduction (defined as K+ ≤5.5 mEq/l and 4 hours without potassium-related medical intervention) at Hours 6 and 8
measure: Potassium level trends after receiving study drug
time frame: Up to 24 hours after study drug dose is given
description: K+ 24 hours after ED discharge
arm group label: Veltassa
arm group type: Active Comparator
description: 3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department
arm group label: Placebo
arm group type: Placebo Comparator
description: 3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department
intervention type: Drug
intervention name: Patiromer Powder for Oral Suspension [Veltassa]
description: Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
arm group label: Veltassa
other name: Active drug
intervention type: Drug
intervention name: Placebo
description: Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
arm group label: Placebo
other name: Inactive substance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Hyperkalemia
sharing ipd: No