<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/NCT03001973</url>
  </required_header>
  <id_info>
    <org_study_id>HELP</org_study_id>
    <nct_id>NCT03001973</nct_id>
  </id_info>
  <brief_title>High Quality Evidence of Chinese Lupus Nephritis (HELP)</brief_title>
  <official_title>High Quality Evidence of Chinese Lupus Nephritis (HELP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are registering LN patients at recruited hospitals and developing a LN&#xD;
      database in China. Patients will be follow-up every year, and both baseline and follow-up&#xD;
      information will be entered into the registration system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are registering Lupus nephritis (LN) and developing a LN database in China.&#xD;
      Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking,&#xD;
      drinking, and education etc.), clinical characteristics (including systolic blood pressure,&#xD;
      diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.),&#xD;
      complications, drug information at the baseline will be collected. Patients will be follow-up&#xD;
      every year, the demographic and clinical characteristics, complications; drug information of&#xD;
      patients will be collected at each visit. We will also record the outcome at each visit, such&#xD;
      as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage&#xD;
      renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival&#xD;
      will be compared using the LN database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality and cardiovascular mortality of LN patients</measure>
    <time_frame>10years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>A composite renal outcome of LN patients</measure>
    <time_frame>10years</time_frame>
    <description>The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>LN patients</arm_group_label>
    <description>Patients diagnosis as lupus nephritis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Registration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.</description>
    <arm_group_label>LN patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The serum, urine, DNA and renal tissue will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Lupus nephritis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who diagnosis as lupus nephritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xueqing Yu, M.D. &amp; Ph.D</last_name>
    <email>yuxq@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Chen, M.D. &amp; Ph.D</last_name>
    <phone>8620-87755766</phone>
    <phone_ext>8843</phone_ext>
    <email>vvchen66@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xueqing Yu, M.D. &amp; Ph.D.</last_name>
      <email>yuxq@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xue Qing Yu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Lupus nephritis</keyword>
  <keyword>Patient survival</keyword>
  <keyword>Renal survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephritis</mesh_term>
    <mesh_term>Lupus Nephritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03001973
org study id: HELP
nct id: NCT03001973
lead sponsor: 
has dmc: Yes
The investigators are registering LN patients at recruited hospitals and developing a LN
      database in China. Patients will be follow-up every year, and both baseline and follow-up
      information will be entered into the registration system.
The investigators are registering Lupus nephritis (LN) and developing a LN database in China.
      Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking,
      drinking, and education etc.), clinical characteristics (including systolic blood pressure,
      diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.),
      complications, drug information at the baseline will be collected. Patients will be follow-up
      every year, the demographic and clinical characteristics, complications; drug information of
      patients will be collected at each visit. We will also record the outcome at each visit, such
      as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage
      renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival
      will be compared using the LN database.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality and cardiovascular mortality of LN patients
time frame: 10years
measure: A composite renal outcome of LN patients
time frame: 10years
description: The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).
arm group label: LN patients
description: Patients diagnosis as lupus nephritis
intervention type: Other
intervention name: No Intervention
description: Registration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
arm group label: LN patients
The serum, urine, DNA and renal tissue will be collected.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Xueqing Yu, M.D. & Ph.D
email: yuxq@mail.sysu.edu.cn
last name: Wei Chen, M.D. & Ph.D
phone: 8620-87755766
phone ext: 8843
email: vvchen66@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xue Qing Yu
investigator title: Professor
mesh term: Nephritis
mesh term: Lupus Nephritis
sharing ipd: Yes