<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/NCT01722695</url>
  </required_header>
  <id_info>
    <org_study_id>1499</org_study_id>
    <nct_id>NCT01722695</nct_id>
  </id_info>
  <brief_title>Performance Comparison of Revaclear With Larger Dialyzer</brief_title>
  <acronym>Revacom HD</acronym>
  <official_title>HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gambro Dialysatoren GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Baxter Healthcare Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to show equivalent performance of the Revaclear dialyzer when&#xD;
      compared to a dialyzer with larger membrane surface area.&#xD;
&#xD;
      Study design: open, randomized, cross-over, multicentric, controlled prospective&#xD;
&#xD;
      Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on&#xD;
      patient needs&#xD;
&#xD;
      Patients/sample size: 30 adult chronic hemodialysis patients&#xD;
&#xD;
      Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions)&#xD;
      with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.&#xD;
&#xD;
      Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of&#xD;
      urea, phosphate, creatinine and ß2-microglobulin; albumin loss&#xD;
&#xD;
      Primary variable: dialysis dose Kt/V urea&#xD;
&#xD;
      Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and&#xD;
      ß2-microglobulin&#xD;
&#xD;
      Safety variable: albumin loss, blood count&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dialysis dose Kt/V urea</measure>
    <time_frame>2 weeks (6 consecutive dialysis sessions)</time_frame>
    <description>Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction rate of urea, creatinine, phosphate and ß2-microglobulin</measure>
    <time_frame>2 weeks (6 consecutive dialysis sessions)</time_frame>
    <description>Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total removal of creatinine, phosphate and ß2-microglobulin</measure>
    <time_frame>2 weeks (6 consecutive dialysis sessions)</time_frame>
    <description>Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin loss</measure>
    <time_frame>2 weeks (6 consecutive dialysis sessions)</time_frame>
    <description>Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood count</measure>
    <time_frame>2 weeks (start and end of 6 consecutive dialysis sessions)</time_frame>
    <description>Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Renal Failure Chronic Requiring Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Revaclear followed by FX</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FX followed by Revaclear</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dialyzer comparison</intervention_name>
    <description>Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).&#xD;
The order of dialyzers used will be randomly assigned to the patient at randomization.</description>
    <arm_group_label>FX followed by Revaclear</arm_group_label>
    <arm_group_label>Revaclear followed by FX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for&#xD;
             at least 3 months&#xD;
&#xD;
          -  patients aged 18 years or more&#xD;
&#xD;
          -  written consent to participate in the study (informed consent)&#xD;
&#xD;
          -  dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate&#xD;
             of at least 300 mL/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  single-needle dialysis&#xD;
&#xD;
          -  pregnant and lactating women&#xD;
&#xD;
          -  participation in other interventional studies less than 3 months prior to study start&#xD;
&#xD;
          -  non-compliance with the dialysis prescription&#xD;
&#xD;
          -  hematocrit less than 28%&#xD;
&#xD;
          -  hospitalization&#xD;
&#xD;
          -  antibiotic therapy&#xD;
&#xD;
          -  active infection&#xD;
&#xD;
          -  active cancer&#xD;
&#xD;
          -  known positive serology for HIV, hepatitis B or C&#xD;
&#xD;
          -  serious hemostasis disorders&#xD;
&#xD;
          -  any comorbidity possibly conflicting with the study purpose or procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Rosenkranz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Graz, Austria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dialyseinstitut Prim. Dr. W. Gießauf GmbH</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</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 Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01722695
org study id: 1499
nct id: NCT01722695
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to show equivalent performance of the Revaclear dialyzer when
      compared to a dialyzer with larger membrane surface area.

      Study design: open, randomized, cross-over, multicentric, controlled prospective

      Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on
      patient needs

      Patients/sample size: 30 adult chronic hemodialysis patients

      Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions)
      with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.

      Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of
      urea, phosphate, creatinine and ß2-microglobulin; albumin loss

      Primary variable: dialysis dose Kt/V urea

      Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and
      ß2-microglobulin

      Safety variable: albumin loss, blood count
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dialysis dose Kt/V urea
time frame: 2 weeks (6 consecutive dialysis sessions)
description: Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.
measure: Reduction rate of urea, creatinine, phosphate and ß2-microglobulin
time frame: 2 weeks (6 consecutive dialysis sessions)
description: Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).
measure: Total removal of creatinine, phosphate and ß2-microglobulin
time frame: 2 weeks (6 consecutive dialysis sessions)
description: Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.
measure: Albumin loss
time frame: 2 weeks (6 consecutive dialysis sessions)
description: Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.
measure: Blood count
time frame: 2 weeks (start and end of 6 consecutive dialysis sessions)
description: Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L).
arm group label: Revaclear followed by FX
arm group type: Other
arm group label: FX followed by Revaclear
arm group type: Other
intervention type: Other
intervention name: Dialyzer comparison
description: Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).
The order of dialyzers used will be randomly assigned to the patient at randomization.
arm group label: FX followed by Revaclear
arm group label: Revaclear followed by FX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Rosenkranz, Prof.
role: Principal Investigator
affiliation: Medical University Graz, Austria
facility: 
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic