<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/NCT02989298</url>
  </required_header>
  <id_info>
    <org_study_id>PD registry</org_study_id>
    <nct_id>NCT02989298</nct_id>
  </id_info>
  <brief_title>Peritoneal Dialysis Registration System (PERSIST)</brief_title>
  <official_title>Peritoneal Dialysis Registration System (PERSIST)</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>
      Brief Summary: The investigators are registering all PD patients at recruited hospitals and&#xD;
      developing a PD database in China. Patients will be followed up every 3 months, and both&#xD;
      baseline and follow-up information will be collected and input into the registration system.&#xD;
      The patient survival, technical survival, peritonitis rate, longitudinal changes of residual&#xD;
      renal function and peritoneum function, and quality of life for PD patients, etc, will be&#xD;
      compared using the PD database.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description: The investigators are registering all end stage renal disease (ESRD)&#xD;
      patients receiving peritoneal dialysis (PD) treatment, and developing a PD database in China.&#xD;
      Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking,&#xD;
      drinking, and education, etc), clinical characteristics (primary cause of ESRD, dialysis&#xD;
      prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug&#xD;
      information, complications and scores of quality of life at the baseline will be collected.&#xD;
      Patients will be followed up every 3 months. Demographic and clinical characteristics,&#xD;
      complications, drug information of patients will be collected at each visit. The patients'&#xD;
      clinical outcomes, such as mortality (including all-cause mortality and cardiovascular&#xD;
      disease mortality), technical survival, kidney transplantation, transfer to hemodialysis,&#xD;
      hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the&#xD;
      study. The data of patient survival, technical survival, peritonitis rate, hospitalization&#xD;
      rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum&#xD;
      function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life&#xD;
      for PD patients will be analyzed using the PD database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2013</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>Patient survival of PD patients</measure>
    <time_frame>10 years</time_frame>
    <description>Patient survival including all-cause and cardiovascular mortality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical survival of PD patients</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>ESRD</condition>
  <condition>Disorders Associated With Peritoneal Dialysis</condition>
  <arm_group>
    <arm_group_label>PD patients</arm_group_label>
    <description>End stage renal disease patients receiving peritoneal dialysis treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Registration of all PD 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>PD patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The serum, urine, DNA and peritoneum tissue will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        ESRD patients receiving PD treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:PD patients -&#xD;
&#xD;
        Exclusion Criteria:No&#xD;
&#xD;
        -&#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>Xueqing Yu, M.D. &amp; Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xueqing Yu, M.D. &amp; Ph.D.</last_name>
    <phone>8620-87766335</phone>
    <email>yuxq@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiao Yang, M.D. &amp; Ph.D.</last_name>
    <phone>8620-87755766</phone>
    <phone_ext>8843</phone_ext>
    <email>yangxsysu@126.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>
      <phone>8620-87766335</phone>
      <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>October 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 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>Peritoneal Dialysis (PD)</keyword>
  <keyword>Residual renal function</keyword>
  <keyword>Peritoneum function</keyword>
  <keyword>Peritonitis rate</keyword>
  <keyword>Technical survival</keyword>
  <keyword>Patient survival</keyword>
  <!-- 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/NCT02989298
org study id: PD registry
nct id: NCT02989298
lead sponsor: 
has dmc: Yes
Brief Summary: The investigators are registering all PD patients at recruited hospitals and
      developing a PD database in China. Patients will be followed up every 3 months, and both
      baseline and follow-up information will be collected and input into the registration system.
      The patient survival, technical survival, peritonitis rate, longitudinal changes of residual
      renal function and peritoneum function, and quality of life for PD patients, etc, will be
      compared using the PD database.
Detailed Description: The investigators are registering all end stage renal disease (ESRD)
      patients receiving peritoneal dialysis (PD) treatment, and developing a PD database in China.
      Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking,
      drinking, and education, etc), clinical characteristics (primary cause of ESRD, dialysis
      prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug
      information, complications and scores of quality of life at the baseline will be collected.
      Patients will be followed up every 3 months. Demographic and clinical characteristics,
      complications, drug information of patients will be collected at each visit. The patients'
      clinical outcomes, such as mortality (including all-cause mortality and cardiovascular
      disease mortality), technical survival, kidney transplantation, transfer to hemodialysis,
      hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the
      study. The data of patient survival, technical survival, peritonitis rate, hospitalization
      rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum
      function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life
      for PD patients will be analyzed using the PD database.
observational model: Cohort
time perspective: Prospective
measure: Patient survival of PD patients
time frame: 10 years
description: Patient survival including all-cause and cardiovascular mortality.
measure: Technical survival of PD patients
time frame: 10 years
arm group label: PD patients
description: End stage renal disease patients receiving peritoneal dialysis treatment
intervention type: Other
intervention name: No intervention
description: Registration of all PD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals，which have signed the contract in China.
arm group label: PD patients
The serum, urine, DNA and peritoneum tissue will be collected.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xueqing Yu, M.D. & Ph.D.
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
last name: Xueqing Yu, M.D. & Ph.D.
phone: 8620-87766335
email: yuxq@mail.sysu.edu.cn
last name: Xiao Yang, M.D. & Ph.D.
phone: 8620-87755766
phone ext: 8843
email: yangxsysu@126.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