<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/NCT03004898</url>
  </required_header>
  <id_info>
    <org_study_id>IWW-0006</org_study_id>
    <nct_id>NCT03004898</nct_id>
  </id_info>
  <brief_title>Population-based Chronic Kidney Disease Cohort at Northern Taiwan</brief_title>
  <official_title>Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CKD is a global endemic disease with increased comorbidities and mortality. The prevalence&#xD;
      and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The&#xD;
      prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk&#xD;
      factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education&#xD;
      deep into the community remains limited. The aims of this study are:&#xD;
&#xD;
        1. Explore risk factors associated with CKD in the community&#xD;
&#xD;
        2. Establish multidisciplinary care model in the community&#xD;
&#xD;
        3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in&#xD;
           behavioral , physiological, immune and metabolomics aspects&#xD;
&#xD;
        4. Provide bio-specimen repository for future study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2013</start_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>eGFR &lt; 60 mL/min</measure>
    <time_frame>through study completion, every 1 year</time_frame>
    <description>change of renal function between groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>albuminuria/creatinine ratio &gt;=30</measure>
    <time_frame>through study completion, every 1 year</time_frame>
    <description>change of proteinuria between groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>proteinuria/creatine ratio &gt;=150</measure>
    <time_frame>through study completion, every 1 year</time_frame>
    <description>change of proteinuria between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>through study completion, every 1 year</time_frame>
    <description>change of score between groups</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Chronic Kidney Disease, Population, Community, Multidisciplinary, Education</condition>
  <arm_group>
    <arm_group_label>education arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>multidisciplinary renal education</intervention_name>
    <description>multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.</description>
    <arm_group_label>education arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  residents of Northern Taiwan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy women, unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Wen Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tsang-Tang Hsieh, MD</last_name>
    <phone>+886-2-27135211</phone>
    <phone_ext>3576</phone_ext>
    <email>tth3388@adm.cgmh.org.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>I-Wen Wu, MD</last_name>
    <phone>+886-2-24313131</phone>
    <phone_ext>3170</phone_ext>
    <email>fliawu@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Nephrology, Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <zip>204</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Wen Wu, MD</last_name>
      <phone>+886-2-24313131</phone>
      <phone_ext>3170</phone_ext>
      <email>fliawu@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>I-Wen Wu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.</citation>
    <PMID>19491379</PMID>
  </reference>
  <reference>
    <citation>Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.</citation>
    <PMID>21414969</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>I Wen Wu, MD</investigator_full_name>
    <investigator_title>MD</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>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03004898
org study id: IWW-0006
nct id: NCT03004898
lead sponsor: 
has dmc: Yes
CKD is a global endemic disease with increased comorbidities and mortality. The prevalence
      and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The
      prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk
      factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education
      deep into the community remains limited. The aims of this study are:

        1. Explore risk factors associated with CKD in the community

        2. Establish multidisciplinary care model in the community

        3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in
           behavioral , physiological, immune and metabolomics aspects

        4. Provide bio-specimen repository for future study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: eGFR < 60 mL/min
time frame: through study completion, every 1 year
description: change of renal function between groups
measure: albuminuria/creatinine ratio >=30
time frame: through study completion, every 1 year
description: change of proteinuria between groups
measure: proteinuria/creatine ratio >=150
time frame: through study completion, every 1 year
description: change of proteinuria between groups
measure: SF-36
time frame: through study completion, every 1 year
description: change of score between groups
arm group label: education arm
arm group type: Experimental
description: multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists.
intervention type: Behavioral
intervention name: multidisciplinary renal education
description: multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.
arm group label: education arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: I-Wen Wu, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Tsang-Tang Hsieh, MD
phone: +886-2-27135211
phone ext: 3576
email: tth3388@adm.cgmh.org.tw
last name: I-Wen Wu, MD
phone: +886-2-24313131
phone ext: 3170
email: fliawu@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
citation: Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.
PMID: 19491379
citation: Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.
PMID: 21414969
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: I Wen Wu, MD
investigator title: MD
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No