<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/NCT03015974</url>
  </required_header>
  <id_info>
    <org_study_id>2015[992]</org_study_id>
    <nct_id>NCT03015974</nct_id>
  </id_info>
  <brief_title>Registry of IgA Nephropathy in Chinese Children</brief_title>
  <acronym>RACC</acronym>
  <official_title>Registry of IgA Nephropathy in Chinese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanjing PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Children's Hospital of Zhejiang University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fuzhou General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Hebei Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangxi Province Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xian Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Capital Institute of Pediatrics, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chengdu Women's and Children's Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People's Hospital of Yunnan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tries to identify the safe and effective treatment option for IgA nephropathy in&#xD;
      children. Investigators will perform prospective registration study among 25 pediatric&#xD;
      nephrology medical centers in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will&#xD;
      be enrolled among 25 pediatric nephrology medical centers nationwide, according to the&#xD;
      following protocol.&#xD;
&#xD;
        1. Establishment of registration database online.&#xD;
&#xD;
        2. Participants will be enrolled according to the inclusion criteria and exclusion&#xD;
           criteria.&#xD;
&#xD;
        3. The following data will be collected prospectively, including demographic data, clinical&#xD;
           symptoms, physical examination, laboratory examination, renal pathology, treatment&#xD;
           protocol and follow-up.&#xD;
&#xD;
        4. SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical&#xD;
           analysis. P value less than 0.05 will be considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Improvement of proteinuria</measure>
    <time_frame>Two years</time_frame>
    <description>Complete remission is defined as 24-hour urine protein&lt;150mg or UPC&lt;0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal dysfunction</measure>
    <time_frame>Two years</time_frame>
    <description>Renal dysfunction is defined as eGFR declined by more than 50%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypertension</measure>
    <time_frame>Two years</time_frame>
    <description>Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>End stage renal disease(ESRD)</measure>
    <time_frame>Two years</time_frame>
    <description>ESRD is defined as eGFR&lt;15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Two years</time_frame>
    <description>Death of participants will be recorded.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>IgA Nephropathy</condition>
  <condition>Proteinuria in Nephrotic Range</condition>
  <condition>Immunosuppressive Treatment</condition>
  <arm_group>
    <arm_group_label>corticosteroid</arm_group_label>
    <description>pediatric IgA nephropathy treated with only corticosteroid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>corticosteroid and cyclophosphamide</arm_group_label>
    <description>pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>corticosteroid and mycophenolate mofetil</arm_group_label>
    <description>pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <arm_group_label>corticosteroid</arm_group_label>
    <arm_group_label>corticosteroid and cyclophosphamide</arm_group_label>
    <arm_group_label>corticosteroid and mycophenolate mofetil</arm_group_label>
    <other_name>Steroid</other_name>
    <other_name>Prednisone</other_name>
    <other_name>Methylprednisone</other_name>
    <other_name>Prednisolone</other_name>
    <other_name>Deflazacort</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <arm_group_label>corticosteroid and cyclophosphamide</arm_group_label>
    <other_name>CTX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate mofetil</intervention_name>
    <arm_group_label>corticosteroid and mycophenolate mofetil</arm_group_label>
    <other_name>MMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dipyridamole</intervention_name>
    <arm_group_label>corticosteroid</arm_group_label>
    <arm_group_label>corticosteroid and cyclophosphamide</arm_group_label>
    <arm_group_label>corticosteroid and mycophenolate mofetil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACE Inhibitor or Angiotensin receptor antagonist</intervention_name>
    <arm_group_label>corticosteroid</arm_group_label>
    <arm_group_label>corticosteroid and cyclophosphamide</arm_group_label>
    <arm_group_label>corticosteroid and mycophenolate mofetil</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The urine, serum and DNA of participants are expected to be collected and preserved.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria&#xD;
        will be enrolled among 25 pediatric nephrology medical centers nationwide.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        In-patients will be enrolled with the following criteria.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of primary IgA nephropathy.&#xD;
&#xD;
          -  Presenting with nephrotic proteinuria, defined as 24-hour urinary protein&gt;50mg/kg, or&#xD;
             UPC&gt;2.0 mg/mg.&#xD;
&#xD;
          -  Informed consent must be signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis,&#xD;
             hepatitis B virus associated nephritis, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Ding, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuhui Zhong, Dr.</last_name>
    <phone>8613683556856</phone>
    <email>xuhui7876@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jie Ding, Prof.</last_name>
    <phone>861083573238</phone>
    <email>djnc_5855@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xuhui Zhong, Dr.</last_name>
      <phone>8613683556856</phone>
      <email>xuhui7876@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Jie Ding</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Proteinuria</mesh_term>
    <mesh_term>Glomerulonephritis, IGA</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Deflazacort</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Dipyridamole</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
    <mesh_term>Angiotensin Receptor Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03015974
org study id: 2015[992]
nct id: NCT03015974
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has dmc: Yes
This study tries to identify the safe and effective treatment option for IgA nephropathy in
      children. Investigators will perform prospective registration study among 25 pediatric
      nephrology medical centers in China.
A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will
      be enrolled among 25 pediatric nephrology medical centers nationwide, according to the
      following protocol.

        1. Establishment of registration database online.

        2. Participants will be enrolled according to the inclusion criteria and exclusion
           criteria.

        3. The following data will be collected prospectively, including demographic data, clinical
           symptoms, physical examination, laboratory examination, renal pathology, treatment
           protocol and follow-up.

        4. SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical
           analysis. P value less than 0.05 will be considered significant.
observational model: Case-Only
time perspective: Prospective
measure: Improvement of proteinuria
time frame: Two years
description: Complete remission is defined as 24-hour urine protein<150mg or UPC<0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function.
measure: Renal dysfunction
time frame: Two years
description: Renal dysfunction is defined as eGFR declined by more than 50%.
measure: Hypertension
time frame: Two years
description: Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.
measure: End stage renal disease(ESRD)
time frame: Two years
description: ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.
measure: Mortality
time frame: Two years
description: Death of participants will be recorded.
arm group label: corticosteroid
description: pediatric IgA nephropathy treated with only corticosteroid
arm group label: corticosteroid and cyclophosphamide
description: pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
arm group label: corticosteroid and mycophenolate mofetil
description: pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
intervention type: Drug
intervention name: Corticosteroid
arm group label: corticosteroid
arm group label: corticosteroid and cyclophosphamide
arm group label: corticosteroid and mycophenolate mofetil
other name: Steroid
other name: Prednisone
other name: Methylprednisone
other name: Prednisolone
other name: Deflazacort
intervention type: Drug
intervention name: Cyclophosphamide
arm group label: corticosteroid and cyclophosphamide
other name: CTX
intervention type: Drug
intervention name: Mycophenolate mofetil
arm group label: corticosteroid and mycophenolate mofetil
other name: MMF
intervention type: Drug
intervention name: Dipyridamole
arm group label: corticosteroid
arm group label: corticosteroid and cyclophosphamide
arm group label: corticosteroid and mycophenolate mofetil
intervention type: Drug
intervention name: ACE Inhibitor or Angiotensin receptor antagonist
arm group label: corticosteroid
arm group label: corticosteroid and cyclophosphamide
arm group label: corticosteroid and mycophenolate mofetil
The urine, serum and DNA of participants are expected to be collected and preserved.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Jie Ding, Prof.
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Xuhui Zhong, Dr.
phone: 8613683556856
email: xuhui7876@126.com
last name: Jie Ding, Prof.
phone: 861083573238
email: djnc_5855@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Jie Ding
investigator title: Prof.
mesh term: Kidney Diseases
mesh term: Proteinuria
mesh term: Glomerulonephritis, IGA
mesh term: Mycophenolic Acid
mesh term: Prednisone
mesh term: Prednisolone
mesh term: Deflazacort
mesh term: Cyclophosphamide
mesh term: Dipyridamole
mesh term: Angiotensin-Converting Enzyme Inhibitors
mesh term: Angiotensin Receptor Antagonists
sharing ipd: Undecided