<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/NCT03812679</url>
  </required_header>
  <id_info>
    <org_study_id>BXU011787</org_study_id>
    <nct_id>NCT03812679</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)</brief_title>
  <official_title>Performance Evaluation of the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System in Patients Using the AMIA APD Cycler</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baxter Healthcare Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peritoneal dialysis (PD) is a well-established treatment for renal failure including&#xD;
      long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal&#xD;
      dialysis or automated peritoneal dialysis (APD).&#xD;
&#xD;
      Complementary therapies offer longer term survival for patients with ESRD. However, none of&#xD;
      them are devoid of side effects and today their limitations are better understood by the&#xD;
      nephrologist.&#xD;
&#xD;
      The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource&#xD;
      Platform (previously cleared) with an in-home water system technology and leverages newly&#xD;
      developed AMIA APD Concentrates.&#xD;
&#xD;
      The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are&#xD;
      indicated for adult patients in acute or chronic renal failure when non-dialytic medical&#xD;
      therapy is judged to be inadequate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated for business reasons not due to scientific data. Sufficient data was acquired to&#xD;
    transition program development to other technologies&#xD;
  </why_stopped>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">February 19, 2020</completion_date>
  <primary_completion_date type="Actual">February 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit</measure>
    <time_frame>Week 1, 4, 8 and 12</time_frame>
    <description>The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit</measure>
    <time_frame>Week 1, 4, 8 and 12</time_frame>
    <description>Microbiological testing within &lt;=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and &lt;0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP &lt;61&gt; and USP &lt;85&gt; and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit</measure>
    <time_frame>Week 1, 4, 8 and 12</time_frame>
    <description>Microbiological testing within &lt;=0 CFU/mL limit for TAMC and TYMC and &lt;0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP &lt;71&gt; and USP &lt;85&gt;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8</measure>
    <time_frame>Baseline, Week 5 or Week 6 or Week 7 or Week 8</time_frame>
    <description>Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>End Stage Renal Disease (ESRD)</condition>
  <arm_group>
    <arm_group_label>AMIA APD Solution Generation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AMIA APD Solution Generation System</intervention_name>
    <description>The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
    <arm_group_label>AMIA APD Solution Generation System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is 18 years or older.&#xD;
&#xD;
          2. Patient with ESRD receiving PD therapy, and who is already trained and regularly using&#xD;
             the AMIA or HomeChoice APD Cycler with Dianeal PD Solution for at least 12 weeks.&#xD;
&#xD;
          3. Patient is receiving or willing and able to use Dianeal Low Calcium (2.5 mEq/L) PD&#xD;
             prescriptive regimen at study treatment initiation per Investigator's assessment.&#xD;
&#xD;
          4. Patient demonstrates adequate PD therapy with clinical euvolemia as assessed by the&#xD;
             Investigator with a total Kt/Vurea of a minimum of 1.7 within 45 days of Screening, or&#xD;
             measured at Screening. If a total Kt/Vurea is not available within 45 days of&#xD;
             Screening, it will be measured at Screening.&#xD;
&#xD;
          5. Investigator assesses that, with appropriate training, the patient will be able to&#xD;
             successfully manage his/her dialysis treatments with the AMIA APD Solution Generation&#xD;
             System.&#xD;
&#xD;
          6. Patient is available and is willing to complete training on the AMIA APD Solution&#xD;
             Generation System.&#xD;
&#xD;
          7. Patient and home environment are deemed suitable for treatment with the AMIA APD&#xD;
             Solution Generation System, while in the home.&#xD;
&#xD;
          8. Home electrical and water assessments meet suitability criteria for the AMIA APD&#xD;
             Solution Generation System.&#xD;
&#xD;
          9. The patient's home has suitable wireless connection or patient is willing to allow&#xD;
             installation of suitable wireless connection.&#xD;
&#xD;
         10. Patient and/or care partner (if participating) is able to read and understand English,&#xD;
             and provide informed consent after an explanation of the proposed study. If the&#xD;
             patient does not read and understand English, patient may still participate if he/she&#xD;
             has a co-residing care partner who reads and understands English, assessed as adequate&#xD;
             by the PI.&#xD;
&#xD;
         11. Women of childbearing potential (not menopausal or surgically sterile) must not be&#xD;
             pregnant. Serum qualitative and quantitative pregnancy test will be done within 14&#xD;
             days prior to initiation of study product.&#xD;
&#xD;
               -  If qualitative serum β-hCG results are positive, repeat quantitative serum&#xD;
                  pregnancy test in 48 hours.&#xD;
&#xD;
               -  If quantitative serum β-hCG levels show clinically significant rise within 48&#xD;
                  hours, serum progesterone level should be taken. Serum progesterone &gt; 5 ng/mL&#xD;
                  will exclude a patient from the study.&#xD;
&#xD;
         12. Sexually active males and females agree to use a reliable means of contraception&#xD;
             during the study and for 30 days afterwards (e.g., oral contraceptive and condom,&#xD;
             intrauterine device and condom, or diaphragm with spermicide and condom).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with a history of PD catheter dysfunction within 12 weeks prior to study&#xD;
             enrollment, as evaluated by the Investigator.&#xD;
&#xD;
          2. Patient who had episodes of peritonitis or exit site infection within 12 weeks prior&#xD;
             to study enrollment.&#xD;
&#xD;
          3. Patient who has signs of impending or current infection including a cloudy dialysis&#xD;
             effluent or dialysis white cell count &gt; 100/ μL or &gt; 0.1 x 109/ L (after a dwell time&#xD;
             of at least 2 hours), with &gt; 50% polymorphonuclear cells, and/or positive dialysis&#xD;
             effluent culture.&#xD;
&#xD;
          4. Patient who has a severe primary immune deficiency or other condition that may mask&#xD;
             clinical signs of peritonitis, as evaluated by the Investigator.&#xD;
&#xD;
          5. Patient with a history of repeated non-compliance with PD, therapy (e.g., a&#xD;
             substantial number of missed clinic visits, missed treatments or a history of&#xD;
             mismanagement of diet or medications), as evaluated by the Investigator.&#xD;
&#xD;
          6. Patient who has acute renal failure with the chance for recovery.&#xD;
&#xD;
          7. Patient who is pre-scheduled for a living donor kidney transplant within the next 6&#xD;
             months.&#xD;
&#xD;
          8. Patient who is not expected to live at least 6 months while maintaining PD treatment.&#xD;
&#xD;
          9. Patient who had major abdominal surgery within 6 months prior to study enrollment.&#xD;
&#xD;
         10. Patient with current abdominal hernia, as evaluated by the Investigator.&#xD;
&#xD;
         11. Patient with advanced liver or pulmonary disease, as evaluated by the Investigator.&#xD;
&#xD;
         12. Positive serology test for Hepatitis B Virus or Hepatitis C Virus infection, or&#xD;
             aspartate transaminase or alanine aminotransferase &gt; 3 x upper limit of normal at&#xD;
             Screening.&#xD;
&#xD;
         13. Patient with diagnosed stage III or IV New York Heart Association (NYHA) heart&#xD;
             failure.&#xD;
&#xD;
         14. Patient who has an active malignancy.&#xD;
&#xD;
         15. History of a clinically significant illness and/or clinically significant surgery&#xD;
             within the past 14 days preceding the Screening Visit as determined by the&#xD;
             Investigator.&#xD;
&#xD;
         16. Patient who is enrolled in another interventional clinical study.&#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>Baxter Investigational Site</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baxter Investigational Site</name>
      <address>
        <city>Fitchburg</city>
        <state>Wisconsin</state>
        <zip>53713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <results_first_submitted>December 15, 2020</results_first_submitted>
  <results_first_submitted_qc>January 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2021</results_first_posted>
  <disposition_first_submitted>March 16, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>January 19, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 5, 2021</disposition_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03812679/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03812679/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AMIA APD Solution Generation System</title>
          <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed &gt;4 consecutive therapy days</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Renal transplant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Termination of study</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Water device replacement</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Set was based on the Intent-to-Treat principle and included all patients who received at least one treatment with the AMIA APD Solution Generation System and who had at least one measurement for the primary endpoint (either primary efficacy or primary safety).</population>
      <group_list>
        <group group_id="B1">
          <title>AMIA APD Solution Generation System</title>
          <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </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="61.9" spread="13.67"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit</title>
        <description>The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
        <time_frame>Week 1, 4, 8 and 12</time_frame>
        <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AMIA APD Solution Generation System</title>
            <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit</title>
          <description>The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
          <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
          <units>Percentage of Tests</units>
          <param>Number</param>
          <units_analyzed>Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (1.5% Dextrose): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (1.5% Dextrose): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (1.5% Dextrose): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (2.5% Dextrose): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (2.5% Dextrose): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (2.5% Dextrose): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (4.25% Dextrose): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (4.25% Dextrose): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (4.25% Dextrose):Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (1.5% Dextrose): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (1.5% Dextrose): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (1.5% Dextrose): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit</title>
        <description>Microbiological testing within &lt;=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and &lt;0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP &lt;61&gt; and USP &lt;85&gt; and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
        <time_frame>Week 1, 4, 8 and 12</time_frame>
        <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AMIA APD Solution Generation System</title>
            <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit</title>
          <description>Microbiological testing within &lt;=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and &lt;0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP &lt;61&gt; and USP &lt;85&gt; and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.</description>
          <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
          <units>Percentage of Tests</units>
          <param>Number</param>
          <units_analyzed>Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1(Visit 1): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1(Visit 1): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1(Visit 1): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit</title>
        <description>Microbiological testing within &lt;=0 CFU/mL limit for TAMC and TYMC and &lt;0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP &lt;71&gt; and USP &lt;85&gt;.</description>
        <time_frame>Week 1, 4, 8 and 12</time_frame>
        <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AMIA APD Solution Generation System</title>
            <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit</title>
          <description>Microbiological testing within &lt;=0 CFU/mL limit for TAMC and TYMC and &lt;0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP &lt;71&gt; and USP &lt;85&gt;.</description>
          <population>Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.</population>
          <units>Percentage of Tests</units>
          <param>Number</param>
          <units_analyzed>Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (Visit 1): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (Visit 1): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (Visit 1): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (Visit 3): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Met Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Did Not Meet Specifications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (Visit 4): Missing Results</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Tests</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8</title>
        <description>Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.</description>
        <time_frame>Baseline, Week 5 or Week 6 or Week 7 or Week 8</time_frame>
        <population>Safety Set</population>
        <group_list>
          <group group_id="O1">
            <title>AMIA APD Solution Generation System</title>
            <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8</title>
          <description>Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.</description>
          <population>Safety Set</population>
          <units>Kt/Vurea</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AMIA APD Solution Generation System</title>
          <description>A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.&#xD;
AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</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="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 20.0">Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </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 Sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated for business reasons not due to scientific data. Sufficient data was acquired to transition program development to other technologies. All enrolled subjects had completed treatment at the time that the US was impacted by COVID-19.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Baxter Clinical Trials Disclosure Call Center</name_or_title>
      <organization>Baxter Healthcare</organization>
      <phone>(224) 948-7359</phone>
      <email>Global_CORP_ClinicalTrialsDisclosure@baxter.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/NCT03812679
org study id: BXU011787
nct id: NCT03812679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Peritoneal dialysis (PD) is a well-established treatment for renal failure including
      long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal
      dialysis or automated peritoneal dialysis (APD).

      Complementary therapies offer longer term survival for patients with ESRD. However, none of
      them are devoid of side effects and today their limitations are better understood by the
      nephrologist.

      The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource
      Platform (previously cleared) with an in-home water system technology and leverages newly
      developed AMIA APD Concentrates.

      The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are
      indicated for adult patients in acute or chronic renal failure when non-dialytic medical
      therapy is judged to be inadequate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
time frame: Week 1, 4, 8 and 12
description: The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
measure: Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
time frame: Week 1, 4, 8 and 12
description: Microbiological testing within <=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and <0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP <61> and USP <85> and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
measure: Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
time frame: Week 1, 4, 8 and 12
description: Microbiological testing within <=0 CFU/mL limit for TAMC and TYMC and <0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP <71> and USP <85>.
measure: Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8
time frame: Baseline, Week 5 or Week 6 or Week 7 or Week 8
description: Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.
arm group label: AMIA APD Solution Generation System
arm group type: Experimental
description: A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
intervention type: Device
intervention name: AMIA APD Solution Generation System
description: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
arm group label: AMIA APD Solution Generation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated for business reasons not due to scientific data. Sufficient data was acquired to transition program development to other technologies. All enrolled subjects had completed treatment at the time that the US was impacted by COVID-19.
point of contact: 