<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/NCT03801226</url>
  </required_header>
  <id_info>
    <org_study_id>2000023570</org_study_id>
    <nct_id>NCT03801226</nct_id>
  </id_info>
  <brief_title>Zero Sodium Peritoneal Dialysate Protocol Pilot Study</brief_title>
  <official_title>Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The following pilot study will be undertaken to determine the effects of use of a zero-sodium&#xD;
      peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared&#xD;
      to a standard peritoneal dialysis solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While heart failure (HF) is generally regarded as the inability of the heart to pump&#xD;
      sufficient blood, on a population level, volume overload is the primary driver of morbidity&#xD;
      and hospitalization. The signs and symptoms of volume overload are driven by water&#xD;
      accumulation, which is initially driven by sodium retention. This overall goal of this study&#xD;
      is to investigate the ability to remove sodium through use of a zero-sodium solution in&#xD;
      peritoneal dialysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event</measure>
    <time_frame>Two hours</time_frame>
    <description>Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of total sodium removed compared to baseline</measure>
    <time_frame>Two hours</time_frame>
    <description>This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Potential Applications for Heart Failure</condition>
  <condition>Volume Overload</condition>
  <arm_group>
    <arm_group_label>10% dextrose in sterile water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dianeal Low-Calcium with 4.25% Dextrose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Two-hour dwell with 10% dextrose in sterile water</intervention_name>
    <description>Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.</description>
    <arm_group_label>10% dextrose in sterile water</arm_group_label>
    <arm_group_label>Dianeal Low-Calcium with 4.25% Dextrose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose</intervention_name>
    <description>Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.</description>
    <arm_group_label>10% dextrose in sterile water</arm_group_label>
    <arm_group_label>Dianeal Low-Calcium with 4.25% Dextrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter&#xD;
&#xD;
          2. PD vintage &lt; 3 years&#xD;
&#xD;
          3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not&#xD;
             dehydrated)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia&#xD;
&#xD;
          2. Systolic blood pressure &lt; 100 mmHg&#xD;
&#xD;
          3. Serum sodium &lt; 130 mEq/L&#xD;
&#xD;
          4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the&#xD;
             peritoneal dialysis catheter&#xD;
&#xD;
          5. Anemia with hemoglobin &lt;8 g/dL&#xD;
&#xD;
          6. Serum bicarbinate &lt; 18 mEq/L&#xD;
&#xD;
          7. Anuric renal failure&#xD;
&#xD;
          8. Inability to give written informed consent or follow study protocol&#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>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</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>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Jeffrey Testani</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Peritoneal dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT03801226
org study id: 2000023570
nct id: NCT03801226
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The following pilot study will be undertaken to determine the effects of use of a zero-sodium
      peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared
      to a standard peritoneal dialysis solution.
While heart failure (HF) is generally regarded as the inability of the heart to pump
      sufficient blood, on a population level, volume overload is the primary driver of morbidity
      and hospitalization. The signs and symptoms of volume overload are driven by water
      accumulation, which is initially driven by sodium retention. This overall goal of this study
      is to investigate the ability to remove sodium through use of a zero-sodium solution in
      peritoneal dialysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
time frame: Two hours
description: Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
measure: Comparison of total sodium removed compared to baseline
time frame: Two hours
description: This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions
arm group label: 10% dextrose in sterile water
arm group type: Experimental
description: Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
arm group label: Dianeal Low-Calcium with 4.25% Dextrose
arm group type: Active Comparator
description: Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
intervention type: Drug
intervention name: Two-hour dwell with 10% dextrose in sterile water
description: Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.
arm group label: 10% dextrose in sterile water
arm group label: Dianeal Low-Calcium with 4.25% Dextrose
intervention type: Drug
intervention name: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
description: Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.
arm group label: 10% dextrose in sterile water
arm group label: Dianeal Low-Calcium with 4.25% Dextrose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Jeffrey Testani
investigator title: Associate Professor of Medicine
mesh term: Heart Failure
mesh term: Calcium