<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/NCT03001947</url>
  </required_header>
  <id_info>
    <org_study_id>INSIGHT</org_study_id>
    <nct_id>NCT03001947</nct_id>
  </id_info>
  <brief_title>IgA Nephropathy Registration Initiative of High Quality (INSIGHT)</brief_title>
  <official_title>IgA Nephropathy Registration Initiative of High Quality (INSIGHT)</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 all biopsy-proven primary IgA nephropathy (IgAN) patients&#xD;
      at recruited hospitals and developing a IgAN database in China. Patients will be follow-up&#xD;
      every one year, and both baseline and follow-up information will be entered into the&#xD;
      registration system. All-cause and cardiovascular mortality and a composite renal outcome of&#xD;
      doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of&#xD;
      dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN&#xD;
      database.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients,&#xD;
      and developing a IgAN database in China. Patients' demographic characteristics (including&#xD;
      age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics&#xD;
      (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab&#xD;
      measurements of serum and urine), complications, drug information at the baseline will be&#xD;
      collected. Patients will be follow-up every one year, the demographic and clinical&#xD;
      characteristics, complications and drug information of patients will be collected at each&#xD;
      visit. The investigators also record the clinical events at each visit, such as mortality&#xD;
      (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as&#xD;
      initiation of dialysis or kidney transplantation) and hospitalization for any cause.&#xD;
      All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum&#xD;
      creatinine and ESRD for IgAN patients will be compared using the IgAN database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>All-cause and cardiovascular mortality of IgAN patients</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>A composite renal outcome of IgAN patients</measure>
    <time_frame>10 years</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">10000</enrollment>
  <condition>IgA Nephropathy</condition>
  <arm_group>
    <arm_group_label>IgAN patients</arm_group_label>
    <description>Biopsy-proven primary IgAN patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Registration of all IgAN 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>IgAN 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>
        Biopsy-proven primary IgAN patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy-proven primary IgAN patients;&#xD;
&#xD;
          2. age ≥14 years old&#xD;
&#xD;
          3. Adequate biopsy sample containing ≥8 glomeruli.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis,&#xD;
        systemic lupus erythematosus, liver cirrhosis and et al; eGFR≤15ml/min/1.73m2 at biopsy.&#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>Qiongqiong Yang, M.D. &amp; Ph.D</last_name>
    <phone>8620-87755766</phone>
    <phone_ext>843</phone_ext>
    <email>qiongqyzzm@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>IgA nephropathy</keyword>
  <keyword>All-cause mortality</keyword>
  <keyword>Cardiovascular mortality</keyword>
  <keyword>A composite renal outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Glomerulonephritis, IGA</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/NCT03001947
org study id: INSIGHT
nct id: NCT03001947
lead sponsor: 
has dmc: Yes
The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients
      at recruited hospitals and developing a IgAN database in China. Patients will be follow-up
      every one year, and both baseline and follow-up information will be entered into the
      registration system. All-cause and cardiovascular mortality and a composite renal outcome of
      doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of
      dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN
      database.
The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients,
      and developing a IgAN database in China. Patients' demographic characteristics (including
      age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics
      (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab
      measurements of serum and urine), complications, drug information at the baseline will be
      collected. Patients will be follow-up every one year, the demographic and clinical
      characteristics, complications and drug information of patients will be collected at each
      visit. The investigators also record the clinical events at each visit, such as mortality
      (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as
      initiation of dialysis or kidney transplantation) and hospitalization for any cause.
      All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum
      creatinine and ESRD for IgAN patients will be compared using the IgAN database.
observational model: Cohort
time perspective: Prospective
measure: All-cause and cardiovascular mortality of IgAN patients
time frame: 10 years
measure: A composite renal outcome of IgAN patients
time frame: 10 years
description: The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).
arm group label: IgAN patients
description: Biopsy-proven primary IgAN patients
intervention type: Other
intervention name: No intervention
description: Registration of all IgAN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
arm group label: IgAN 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: Qiongqiong Yang, M.D. & Ph.D
phone: 8620-87755766
phone ext: 843
email: qiongqyzzm@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: Kidney Diseases
mesh term: Glomerulonephritis, IGA
sharing ipd: Yes