xml: <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/NCT06002529</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023-077</org_study_id>
      <nct_id>NCT06002529</nct_id>
    </id_info>
    <brief_title>Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients</brief_title>
    <official_title>Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        1.1Primary Objective To evaluate the clearance rate of uremic toxin β2-microglobulin (β2-MG),&#xD;
        indoxyl sulfate and λ-free light chain (λFLC) by HFR.&#xD;
  &#xD;
        1.2Secondary Objectives 1.1.1 To evaluate the clearance of low molecular weight uremic toxin&#xD;
        urea (spKt/V, URR).&#xD;
  &#xD;
        1.1.2 To evaluate the clearance of other middle molecules and macromolecular uremic toxins,&#xD;
        including α1-microglobulin (α1-MG), κ-free light chain (κFLC), homocysteine (Hcy),&#xD;
        interleukin-6 (IL-6), p-cresol, YKL-40, complement factor D (CFD), leptin, hippuric acid,&#xD;
        trimethylamine oxide (TMAO), asymmetric dimethylarginine (ADMA), tumor necrosis factor-α&#xD;
        (TNF- α), myoglobin, fibroblast growth factor 23 (FGF23) and intact parathyroid hormone&#xD;
        (iPTH).&#xD;
  &#xD;
        1.1.3 To evaluate the clearance of serum albumin, branched chain amino acids and vitamins A,&#xD;
        C, E.&#xD;
  &#xD;
        1.1.4 To evaluate the comfort of HFR treatment for MHD patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 18, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC)</measure>
      <time_frame>1 day</time_frame>
      <description>The concentrations of β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) were measured before and after HFR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Single-compartment urea clearance index (spKt/V), Urea Reduction Ratio</measure>
      <time_frame>1 day</time_frame>
      <description>Calculate spKt/V and Urea Reduction Ratio.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>other middle molecules and macromolecular uremic including α1-MG, κFLC, Hcy, IL-6, p-cresol, YKL-40, CFD, leptin, hippuric acid, TMAO, ADMA, TNF-α, myoglobin, FGF23 and iPTH</measure>
      <time_frame>1 day</time_frame>
      <description>The concentrations of other middle molecules and macromolecular uremic were measured before and after HFR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serum albumin, branched chain amino acids and vitamins A, C, E</measure>
      <time_frame>1 day</time_frame>
      <description>The concentrations of serum albumin, branched chain amino acids and vitamins A, C, E before and after HFR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the comfort of HFR treatment</measure>
      <time_frame>1 day</time_frame>
      <description>The dialysis comfort score was used for evaluation</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>To Evaluate the Clearance Rate of Uremic Toxin by HFR</condition>
    <arm_group>
      <arm_group_label>HFR treatment</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patient received HFR treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>HFR</intervention_name>
      <description>patient received HFR treatment</description>
      <arm_group_label>HFR treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-75 years old, regardless of gender.&#xD;
  &#xD;
            -  MHD for at least 3 months, and blood purification treatment for 3 times per week.&#xD;
  &#xD;
            -  The vascular access is autogenous arteriovenous fistula or artificial blood&#xD;
               vessels，with a blood flow ≥200mL/min.&#xD;
  &#xD;
            -  spKt/V≥1.2.&#xD;
  &#xD;
            -  Patients who signed the informed consent form (ICF) voluntarily.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have participated in other interventional clinical trials within a month.&#xD;
  &#xD;
            -  Pregnant or lactating women.&#xD;
  &#xD;
            -  Patients of NYHA class IV or occurred acute coronary syndrome or myocardial infarction&#xD;
               in 3 months before the start of the study.&#xD;
  &#xD;
            -  Patients with active hemorrhage in 2 weeks (e.g., cerebral hemorrhage,&#xD;
               gastrointestinal hemorrhage, fundus hemorrhage, etc.).&#xD;
  &#xD;
            -  Patients with unstable blood pressure (pre-dialysis systolic blood pressure ≥180 or&#xD;
               ≤90mmHg, pre-dialysis diastolic blood pressure ≥100 or ≤60mmHg), severe anemia&#xD;
               (hemoglobin ≤60g/L), and high risk of blood coagulation (e.g., albumin ≤25g/L or&#xD;
               hemoglobin ≥140g/L).&#xD;
  &#xD;
            -  Patients with severe infection (the level of hypersensitive C-reactive protein(hsCRP)&#xD;
               ≥ 10×upper limit of normal).&#xD;
  &#xD;
            -  Patients with a history of drug addiction or severe mental disorders.&#xD;
  &#xD;
            -  Other conditions in which the investigators reject patients to participate in this&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Renhua Lu</last_name>
      <phone>+8613361958582</phone>
      <email>lurenhua1977@hotmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>RenJi Hospital</investigator_affiliation>
      <investigator_full_name>Renhua Lu</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002529
  org study id: KY2023-077
  nct id: NCT06002529
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  1.1Primary Objective To evaluate the clearance rate of uremic toxin β2-microglobulin (β2-MG),
        indoxyl sulfate and λ-free light chain (λFLC) by HFR.
  
        1.2Secondary Objectives 1.1.1 To evaluate the clearance of low molecular weight uremic toxin
        urea (spKt/V, URR).
  
        1.1.2 To evaluate the clearance of other middle molecules and macromolecular uremic toxins,
        including α1-microglobulin (α1-MG), κ-free light chain (κFLC), homocysteine (Hcy),
        interleukin-6 (IL-6), p-cresol, YKL-40, complement factor D (CFD), leptin, hippuric acid,
        trimethylamine oxide (TMAO), asymmetric dimethylarginine (ADMA), tumor necrosis factor-α
        (TNF- α), myoglobin, fibroblast growth factor 23 (FGF23) and intact parathyroid hormone
        (iPTH).
  
        1.1.3 To evaluate the clearance of serum albumin, branched chain amino acids and vitamins A,
        C, E.
  
        1.1.4 To evaluate the comfort of HFR treatment for MHD patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC)
  time frame: 1 day
  description: The concentrations of β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) were measured before and after HFR
  measure: Single-compartment urea clearance index (spKt/V), Urea Reduction Ratio
  time frame: 1 day
  description: Calculate spKt/V and Urea Reduction Ratio.
  measure: other middle molecules and macromolecular uremic including α1-MG, κFLC, Hcy, IL-6, p-cresol, YKL-40, CFD, leptin, hippuric acid, TMAO, ADMA, TNF-α, myoglobin, FGF23 and iPTH
  time frame: 1 day
  description: The concentrations of other middle molecules and macromolecular uremic were measured before and after HFR
  measure: serum albumin, branched chain amino acids and vitamins A, C, E
  time frame: 1 day
  description: The concentrations of serum albumin, branched chain amino acids and vitamins A, C, E before and after HFR
  measure: the comfort of HFR treatment
  time frame: 1 day
  description: The dialysis comfort score was used for evaluation
  arm group label: HFR treatment
  arm group type: Other
  description: patient received HFR treatment
  intervention type: Other
  intervention name: HFR
  description: patient received HFR treatment
  arm group label: HFR treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Renhua Lu
  phone: +8613361958582
  email: lurenhua1977@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: RenJi Hospital
  investigator full name: Renhua Lu
  investigator title: chief physician
  sharing ipd: No