<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/NCT03836508</url>
  </required_header>
  <id_info>
    <org_study_id>1909</org_study_id>
    <nct_id>NCT03836508</nct_id>
  </id_info>
  <brief_title>Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis</brief_title>
  <official_title>Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to&#xD;
      high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months&#xD;
      crossovers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of pre and post-dialysis of Interleukin (IL) 17-A</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of IL-17A</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of IL-10</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of IL-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of Interferon (IFN) gama</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of IFN gama</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis necrosis factor (TNF) alpha</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of TNF alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of IL-4</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of IL-4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of Urea</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of Urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of creatinine</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of beta2 microglobulin</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of beta2 microglobulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of free light chain kappa</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of free light chain kappa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of free light chain lambda</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of free light chain lambda</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of myoglobulin</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of myoglobulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis of FGF 23</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis IL-18 levels</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis IL-18 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis MCP-1 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis NLRP3 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of pre and post-dialysis RANTES</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Kidney Failure</condition>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Dialysis Related Complication</condition>
  <arm_group>
    <arm_group_label>Medium cut-off</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-flux</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medium cut-off</intervention_name>
    <description>All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius.&#xD;
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min</description>
    <arm_group_label>High-flux</arm_group_label>
    <arm_group_label>Medium cut-off</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-Flux</intervention_name>
    <description>All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp.&#xD;
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min</description>
    <arm_group_label>High-flux</arm_group_label>
    <arm_group_label>Medium cut-off</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are older than 18 years and younger than 65 years&#xD;
&#xD;
          -  patient with end-stage renal disease, hemodialysis more than 6 months&#xD;
&#xD;
          -  patients under hemodialysis with high-flux dialyzer more than 3 months&#xD;
&#xD;
          -  patients willing to participate after given fair and clear information about study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients living with Hepatitis B or C,&#xD;
&#xD;
          -  patients with malignancy&#xD;
&#xD;
          -  patients under immunosuppressive treatment&#xD;
&#xD;
          -  patients with autoimmune diseases such as systemic lupus erythematosus, etc.&#xD;
&#xD;
          -  patients with active infections&#xD;
&#xD;
          -  patients planned to have a kidney transplantation in 6 months&#xD;
&#xD;
          -  patients having vascular access problems&#xD;
&#xD;
          -  patients planned to transfer to another center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustafa Sevinc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sisli Hamidiye Etfal Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sisli Hamidiye Etfal Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Nuri Baris Hasbal</investigator_full_name>
    <investigator_title>Principal Investigator, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03836508/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03836508
org study id: 1909
nct id: NCT03836508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to
      high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months
      crossovers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Comparison of pre and post-dialysis of Interleukin (IL) 17-A
time frame: 3 months
description: Comparison of pre and post-dialysis of IL-17A
measure: Comparison of pre and post-dialysis of IL-10
time frame: 3 months
description: Comparison of pre and post-dialysis of IL-10
measure: Comparison of pre and post-dialysis of Interferon (IFN) gama
time frame: 3 months
description: Comparison of pre and post-dialysis of IFN gama
measure: Comparison of pre and post-dialysis necrosis factor (TNF) alpha
time frame: 3 months
description: Comparison of pre and post-dialysis of TNF alpha
measure: Comparison of pre and post-dialysis of IL-4
time frame: 3 months
description: Comparison of pre and post-dialysis of IL-4
measure: Comparison of pre and post-dialysis of Urea
time frame: 3 months
description: Comparison of pre and post-dialysis of Urea
measure: Comparison of pre and post-dialysis of creatinine
time frame: 3 months
description: Comparison of pre and post-dialysis of creatinine
measure: Comparison of pre and post-dialysis of beta2 microglobulin
time frame: 3 months
description: Comparison of pre and post-dialysis of beta2 microglobulin
measure: Comparison of pre and post-dialysis of free light chain kappa
time frame: 3 months
description: Comparison of pre and post-dialysis of free light chain kappa
measure: Comparison of pre and post-dialysis of free light chain lambda
time frame: 3 months
description: Comparison of pre and post-dialysis of free light chain lambda
measure: Comparison of pre and post-dialysis of myoglobulin
time frame: 3 months
description: Comparison of pre and post-dialysis of myoglobulin
measure: Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23
time frame: 3 months
description: Comparison of pre and post-dialysis of FGF 23
measure: Comparison of pre and post-dialysis IL-18 levels
time frame: 3 months
description: Comparison of pre and post-dialysis IL-18 levels
measure: Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels
time frame: 3 months
description: Comparison of pre and post-dialysis MCP-1 levels
measure: Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels
time frame: 3 months
description: Comparison of pre and post-dialysis NLRP3 levels
measure: Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)
time frame: 3 months
description: Comparison of pre and post-dialysis RANTES
arm group label: Medium cut-off
arm group type: Active Comparator
description: Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers.
arm group label: High-flux
arm group type: Active Comparator
description: High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers.
intervention type: Device
intervention name: Medium cut-off
description: All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min
arm group label: High-flux
arm group label: Medium cut-off
intervention type: Device
intervention name: High-Flux
description: All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min
arm group label: High-flux
arm group label: Medium cut-off
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mustafa Sevinc, MD
role: Principal Investigator
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Nuri Baris Hasbal
investigator title: Principal Investigator, MD
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
sharing ipd: No
provided document: 