<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/NCT03227770</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-017</org_study_id>
    <nct_id>NCT03227770</nct_id>
  </id_info>
  <brief_title>The Benefit of Hemodialysis Plus Hemoperfusion on Mortality</brief_title>
  <official_title>A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yangpu District Central Hospital Affiliated to Tongji University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      This multi-center, open-label, randomized controlled trial aims to investigate the efficacy&#xD;
      of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and&#xD;
      cardiovascular mortality in maintenance hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven&#xD;
      medical centers in Shanghai Metropolitan area have explicitly expressed interest to&#xD;
      participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or&#xD;
      hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will&#xD;
      receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or&#xD;
      hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition&#xD;
      to the treatments in the control arm, hemoperfusion will be conducted at least once every two&#xD;
      weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is&#xD;
      scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the&#xD;
      following: routine physical examinations, standard lab panels (blood routine, liver/kidney&#xD;
      functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram,&#xD;
      echocardiography, heart function rating (based on New York Heart Association grading).&#xD;
      Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be&#xD;
      assessed according to the international conference on harmonization guidelines. The primary&#xD;
      outcomes will include 24-month all-cause mortality. Secondary outcomes will include&#xD;
      cardiovascular-related mortality, the occurrence of major cardiovascular events and the&#xD;
      quality of life (Kidney Disease Quality of Life Short Form).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>From date of enrollment until the end of study, assessed up to 24 months</time_frame>
    <description>Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular-related mortality and major cardiovascular events (MACEs)</measure>
    <time_frame>From date of enrollment until the end of study, assessed up to 24 months</time_frame>
    <description>Major cardiovascular events events including angina pectoris, acute myocardial infarction, severe arrhythmia, congestive heart failure, myocarditis, pericarditis, cardiac surgery or peripheral vascular surgery, stroke and peripheral vascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of quality of life</measure>
    <time_frame>From date of enrollment until the end of study, assessed up to 24 months</time_frame>
    <description>Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1362</enrollment>
  <condition>End-stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>regular hemodialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hemoperfusion combined with hemodialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of hemodialysis and hemoperfusion treatment at least once every two week</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hemoperfusion combined with hemodialysis</intervention_name>
    <description>Hemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)</description>
    <arm_group_label>hemoperfusion combined with hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hemodialysis</intervention_name>
    <description>Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week</description>
    <arm_group_label>hemoperfusion combined with hemodialysis</arm_group_label>
    <arm_group_label>regular hemodialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients must meet all of the following criteria are eligible:&#xD;
&#xD;
          1. Age ≥ 18 years old&#xD;
&#xD;
          2. Regular blood purification treatment at least 3 months before enrolled in this study&#xD;
&#xD;
        3) Standard Kt/V ≥ 1.2&#xD;
&#xD;
        Subjects with one of more of the following conditions will be excluded:&#xD;
&#xD;
          1. White blood cell count &lt; 4×10^9/L and / or platelet count &lt; 100×10^9/L&#xD;
&#xD;
          2. Cerebral hemorrhage in the past 12 weeks&#xD;
&#xD;
          3. MACEs in the past 8 weeks&#xD;
&#xD;
          4. Severe heart failure (New York Heart Association [NYHA] class IV)&#xD;
&#xD;
          5. Active gastrointestinal bleeding, or coagulation dysfunction&#xD;
&#xD;
          6. Malignant tumor&#xD;
&#xD;
          7. Active infection&#xD;
&#xD;
          8. Pregnancy or lactation 9) Mental disabilities&#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>Gengru Jiang, doctoral</last_name>
    <role>Study Director</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longhua Hospital Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RenJi Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai 6th People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yangpu District Central Hospital Affiliated to Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Gengru Jiang</investigator_full_name>
    <investigator_title>Director of Renal Division, Department of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Hemoperfusion</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Mortality</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The mortality data will be shared</ipd_description>
  </patient_data>
  <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>April 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03227770/Prot_002.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/NCT03227770
org study id: XH-16-017
nct id: NCT03227770
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-center, open-label, randomized controlled trial aims to investigate the efficacy
      of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and
      cardiovascular mortality in maintenance hemodialysis patients.
In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven
      medical centers in Shanghai Metropolitan area have explicitly expressed interest to
      participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or
      hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will
      receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or
      hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition
      to the treatments in the control arm, hemoperfusion will be conducted at least once every two
      weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is
      scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the
      following: routine physical examinations, standard lab panels (blood routine, liver/kidney
      functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram,
      echocardiography, heart function rating (based on New York Heart Association grading).
      Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be
      assessed according to the international conference on harmonization guidelines. The primary
      outcomes will include 24-month all-cause mortality. Secondary outcomes will include
      cardiovascular-related mortality, the occurrence of major cardiovascular events and the
      quality of life (Kidney Disease Quality of Life Short Form).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality
time frame: From date of enrollment until the end of study, assessed up to 24 months
description: Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment
measure: Cardiovascular-related mortality and major cardiovascular events (MACEs)
time frame: From date of enrollment until the end of study, assessed up to 24 months
description: Major cardiovascular events events including angina pectoris, acute myocardial infarction, severe arrhythmia, congestive heart failure, myocarditis, pericarditis, cardiac surgery or peripheral vascular surgery, stroke and peripheral vascular disease
measure: Evaluation of quality of life
time frame: From date of enrollment until the end of study, assessed up to 24 months
description: Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire
arm group label: regular hemodialysis
arm group type: Active Comparator
description: Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
arm group label: hemoperfusion combined with hemodialysis
arm group type: Experimental
description: Combination of hemodialysis and hemoperfusion treatment at least once every two week
intervention type: Device
intervention name: hemoperfusion combined with hemodialysis
description: Hemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)
arm group label: hemoperfusion combined with hemodialysis
intervention type: Device
intervention name: hemodialysis
description: Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
arm group label: hemoperfusion combined with hemodialysis
arm group label: regular hemodialysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gengru Jiang, doctoral
role: Study Director
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Gengru Jiang
investigator title: Director of Renal Division, Department of Internal Medicine
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided
ipd description: The mortality data will be shared
provided document: 