<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/NCT03001934</url>
  </required_header>
  <id_info>
    <org_study_id>SUCCESS</org_study_id>
    <nct_id>NCT03001934</nct_id>
  </id_info>
  <brief_title>Super Chinese Nephrotic Syndrome Registration System (SUCCESS)</brief_title>
  <official_title>Super Chinese Nephrotic Syndrome Registration System (SUCCESS)</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 nephrotic syndrome (NS) patients regardless of the&#xD;
      primary causes and developing a NS database in China. Patients will be followed-up and both&#xD;
      baseline and follow-up information will be recorded in the registration system. The treatment&#xD;
      response, longitudinal changes of renal function, renal survival, patient survival, infection&#xD;
      events and acute kidney injury etc, will be analyzed using the NS database.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are registering all NS patients regardless of the primary causes in China.&#xD;
      Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking,&#xD;
      drinking, and education), clinical characteristics (including systolic blood pressure,&#xD;
      diastolic blood pressure, primary cause of NS, and lab measurements of serum, urine),&#xD;
      pathological characteristics, treatment and treatment response, complications and outcomes.&#xD;
      Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests&#xD;
      of blood and urine and complications of patients will be collected and recorded at each&#xD;
      visit. The investigators also record the outcome at each visit, such as treatment response,&#xD;
      longitudinal changes of renal function, hospitalization, occurrence of infection or&#xD;
      cardiovascular events etc. The outcomes will be analyzed using the NS database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2028</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>The patient survival in NS patients</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal survival in NS patients</measure>
    <time_frame>10 years</time_frame>
    <description>Renal survival including end stage renal disease, dialysis, renal transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longitudinal changes of renal function of NS patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response of NS patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection rate of NS patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Nephrotic Syndrome</condition>
  <arm_group>
    <arm_group_label>Nephrotic syndrome patients</arm_group_label>
    <description>Patients diagnosis as nephrotic syndrome (NS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Registration of all NS 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>Nephrotic syndrome 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>
        Nephrotic syndrome patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nephrotic syndrome patients regardless of the primary causes&#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>Naya Huang, M.D. &amp; Ph.D</last_name>
    <email>huangnaya@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The 1st Affiliated Hospital, Sun Yet-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>
    <investigator>
      <last_name>Xueqing Yu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Nephrotic syndrome</keyword>
  <keyword>Treatment response</keyword>
  <keyword>Renal function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrotic Syndrome</mesh_term>
    <mesh_term>Nephrosis</mesh_term>
    <mesh_term>Syndrome</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/NCT03001934
org study id: SUCCESS
nct id: NCT03001934
lead sponsor: 
has dmc: Yes
The investigators are registering all nephrotic syndrome (NS) patients regardless of the
      primary causes and developing a NS database in China. Patients will be followed-up and both
      baseline and follow-up information will be recorded in the registration system. The treatment
      response, longitudinal changes of renal function, renal survival, patient survival, infection
      events and acute kidney injury etc, will be analyzed using the NS database.
The investigators are registering all NS patients regardless of the primary causes 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 NS, and lab measurements of serum, urine),
      pathological characteristics, treatment and treatment response, complications and outcomes.
      Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests
      of blood and urine and complications of patients will be collected and recorded at each
      visit. The investigators also record the outcome at each visit, such as treatment response,
      longitudinal changes of renal function, hospitalization, occurrence of infection or
      cardiovascular events etc. The outcomes will be analyzed using the NS database.
observational model: Cohort
time perspective: Prospective
measure: The patient survival in NS patients
time frame: 10 years
measure: Renal survival in NS patients
time frame: 10 years
description: Renal survival including end stage renal disease, dialysis, renal transplantation
measure: Longitudinal changes of renal function of NS patients
time frame: 10 years
measure: Treatment response of NS patients
time frame: 10 years
measure: Infection rate of NS patients
time frame: 10 years
arm group label: Nephrotic syndrome patients
description: Patients diagnosis as nephrotic syndrome (NS)
intervention type: Other
intervention name: No intervention
description: Registration of all NS patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
arm group label: Nephrotic syndrome 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: Naya Huang, M.D. & Ph.D
email: huangnaya@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xue Qing Yu
investigator title: Professor
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Syndrome
sharing ipd: Yes