<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/NCT03041987</url>
  </required_header>
  <id_info>
    <org_study_id>2011BAI10B01</org_study_id>
    <nct_id>NCT03041987</nct_id>
  </id_info>
  <brief_title>Chinese Cohort Study of Chronic Kidney Disease</brief_title>
  <acronym>C-STRIDE</acronym>
  <official_title>Chinese Cohort Study of Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dongzhimen Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Boai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Shenzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guizhou Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chengdu Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>the Affiliated Hospital of Hubei Traditional Chinese Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chifeng Second Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of BaoTou Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Shanxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minhang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Second Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>the First Affiliated Hospital of the Medical College of Shihezi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yuxi City People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shengjing Hospital</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 aimed to explore underlying mechanisms of chronic kidney disease progression and&#xD;
      its association with adverse consequences. It will enroll approximately 5000 pre-dialysis&#xD;
      chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up&#xD;
      for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and&#xD;
      biomaterials will be collected at baseline and annually. The principal clinical outcomes of&#xD;
      the study consist of renal disease events, cardiovascular events, and death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms&#xD;
      of chronic kidney disease progression and its association with adverse consequences. The&#xD;
      study will establish a baseline cohort of 5000 Chinese pre-dialysis chronic kidney disease&#xD;
      patients, who will be followed up until death or dropout or starting renal replacement&#xD;
      therapy. The follow-up will be conducted for at least 5 years. Their clinical information and&#xD;
      biomaterials will be collected at baseline and then annually during follow-up.&#xD;
&#xD;
      The baseline visit includes the following items: detailed demographics; socioeconomic and&#xD;
      health care services information; medical and family history; medication history; and&#xD;
      questionnaires concerning quality of life, health behaviors, depressive and anxiety symptoms,&#xD;
      cognitive function, and physical activity. Anthropometric measures (height, weight, waist&#xD;
      circumference, hip circumference, resting blood pressure, heart rate, grip strength, and&#xD;
      15-feet measured walk) will also be collected. The laboratory parameters of chemistry test,&#xD;
      intact parathyroid hormone, 24-hour urine electrolytes, protein creatinine ratio, and albumin&#xD;
      creatinine ratio should also be collected for each participant and measured in the central&#xD;
      laboratory. After the baseline visit, participants will return annually for follow-up visits&#xD;
      and evaluation. The evaluating items of follow-up visits are similar to the baseline visit,&#xD;
      and sample collection.&#xD;
&#xD;
      The principal clinical outcomes of the study can be broadly categorized as renal disease&#xD;
      events, cardiovascular events, and death. Renal disease events include the incident end stage&#xD;
      renal disease or significant loss of renal function.Cardiovascular events include acute&#xD;
      myocardial infarction, unstable angina, hospitalization for congestive heart failure,&#xD;
      incident serious cardiac arrhythmia, cerebrovascular events, and peripheral vascular&#xD;
      diseases. Death is further clarified as cardiac, cerebrovascular, renal, others, or unknown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>End stage renal disease or significant loss of renal function</measure>
    <time_frame>from date of baseline examination until the date of first documented end stage renal disease or significant loss of renal function or date of death from any cause, whichever came first, up to 60 months</time_frame>
    <description>start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate &lt;15 ml/minute per 1.73m(2) or halving of estimated glomerular filtration rate or doubling of serum creatinine compared with the value of study entry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>from date of baseline examination until the date of first documented cardiovascular events or date of death from any cause, whichever came first, up to 60 months</time_frame>
    <description>acute myocardial infarction, unstable angina, hospitalization for congestive heart failure, incident serious cardiac arrhythmia (resuscitated cardiac arrest, ventricular fibrillation, sustained ventricular tachycardia, paroxysmal ventricular tachycardia, an initial episode of atrial fibrillation or flutter, severe bradycardia or heart block), cerebrovascular events (intraparenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, cardioembolic cerebral infarction, etc.), and peripheral vascular diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>from date of baseline examination until the date of death from any cause, up to 60 months</time_frame>
    <description>death from any cause</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <arm_group>
    <arm_group_label>Chronic Kidney Disease</arm_group_label>
    <description>Specified estimated glomerular filtration rate (eGFR) range according to different CKD etiologies. For glomerular nephrology patients, the eGFR should be ≥15 ml/minute per 1.73m(2). For diabetic nephrology patients, the defining eligibility was 15 ml/minute per 1.73m(2)≤eGFR &lt;60 ml/minute per 1.73m(2) or eGFR≥ 60 ml/minute per 1.73m(2) with &quot;nephrotic range&quot; proteinuria, which is defined as 24-hour urinary protein ≥3.5 g or urinary albumin creatinine ratio ≥2 000 mg/g or corresponding values of urine dipstick test or urinary protein creatinine ratio. For non-glomerular nephrology and non-diabetic nephrology patients, 15 ml/minute per 1.73m(2) ≤eGFR&lt;60 ml/minute per 1.73m(2) is set for enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc</intervention_name>
    <arm_group_label>Chronic Kidney Disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples Urine samples DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study enrolled chronic kidney disease patients with a broad spectrum of renal diseases&#xD;
        with various severities and phenotypes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants should meet the following criteria of enrollment according to their etiology&#xD;
        of nephrology.&#xD;
&#xD;
          -  For glomerular nephrology patients, the estimated glomerular filtration rate (eGFR)&#xD;
             should be ≥15 ml/minute per 1.73m(2).&#xD;
&#xD;
          -  For diabetic nephrology patients, the defining eligibility was 15 ml/minute per&#xD;
             1.73m(2) ≤eGFR&lt;60 ml/minute per 1.73m(2) or eGFR≥ 60 ml/minute per 1.73m(2) with&#xD;
             &quot;nephrotic range&quot; proteinuria, which is defined as 24-hour urinary protein ≥3.5 g or&#xD;
             urinary albumin creatinine ratio (ACR) ≥2 000 mg/g or corresponding values of urine&#xD;
             dipstick test or urinary protein creatinine ratio (PCR).&#xD;
&#xD;
          -  For non-glomerular nephrology and non-diabetic nephrology patients, 15 ml/minute per&#xD;
             1.73m(2)≤eGFR&lt;60 ml/minute per 1.73m(2) is set for enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants meeting even one of the listed items should be excluded.&#xD;
&#xD;
          -  NYHA Class III or IV heart failure.&#xD;
&#xD;
          -  Chronic kidney disease caused by systemic inflammatory illness or autoimmune disease,&#xD;
             such as lupus erythematosus.&#xD;
&#xD;
          -  Treated with immunosuppressive agents in the preceding 6 months to treat renal or&#xD;
             immune disease.&#xD;
&#xD;
          -  Self-reported or known diagnosis of HIV infection and/or AIDS.&#xD;
&#xD;
          -  Isolated hematuria.&#xD;
&#xD;
          -  Self-reported or known diagnosis of cirrhosis.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Malignancy treated with chemotherapy within last 2 years.&#xD;
&#xD;
          -  Renal or other transplantation.&#xD;
&#xD;
          -  Hereditary kidney disease.&#xD;
&#xD;
          -  Participation in interventional clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Minghui Zhao, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang Wang, MD</last_name>
    <phone>011-86-10-83575535</phone>
    <email>wangfang@bjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunfei Bao, MS</last_name>
    <phone>011-86-10-83575535</phone>
    <email>ckdcohort@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunfei Bao, MS</last_name>
      <phone>011-86-10-83575535</phone>
      <email>ckdcohort@163.com</email>
    </contact>
    <investigator>
      <last_name>Luxia Zhang, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gao B, Zhang L, Wang H, Zhao M. Chinese cohort study of chronic kidney disease: design and methods. Chin Med J (Engl). 2014;127(11):2180-5.</citation>
    <PMID>24902678</PMID>
  </reference>
  <results_reference>
    <citation>Zhou C, Wang F, Wang JW, Zhang LX, Zhao MH. Mineral and Bone Disorder and Its Association with Cardiovascular Parameters in Chinese Patients with Chronic Kidney Disease. Chin Med J (Engl). 2016 Oct 5;129(19):2275-80. doi: 10.4103/0366-6999.190678.</citation>
    <PMID>27647184</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuan J, Zou XR, Han SP, Cheng H, Wang L, Wang JW, Zhang LX, Zhao MH, Wang XQ; C-STRIDE study group. Prevalence and risk factors for cardiovascular disease among chronic kidney disease patients: results from the Chinese cohort study of chronic kidney disease (C-STRIDE). BMC Nephrol. 2017 Jan 14;18(1):23. doi: 10.1186/s12882-017-0441-9.</citation>
    <PMID>28088175</PMID>
  </results_reference>
  <results_reference>
    <citation>Peng Z, Wang J, Yuan Q, Xiao X, Xu H, Xie Y, Wang W, Huang L, Zhong Y, Ao X, Zhang L, Zhao M, Tao L, Zhou Q; C-STRIDE study group. Clinical features and CKD-related quality of life in patients with CKD G3a and CKD G3b in China: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). BMC Nephrol. 2017 Oct 13;18(1):311. doi: 10.1186/s12882-017-0725-0.</citation>
    <PMID>29029600</PMID>
  </results_reference>
  <results_reference>
    <citation>Yan Z, Wang Y, Li S, Wang J, Zhang L, Tan H, Li S, Yang L, Pei H, Zhang L, Wang Y, Duan J, Jiao S, Zhao M, Fu S; China National Survey of Chronic Kidney Disease Working Group. Hypertension Control in Adults With CKD in China: Baseline Results From the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Am J Hypertens. 2018 Mar 10;31(4):486-494. doi: 10.1093/ajh/hpx222.</citation>
    <PMID>29304216</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang JJ, Yang L, Huang JW, Liu YJ, Wang JW, Zhang LX, Zhao MH, Liu ZS. Characteristics and comparison between diabetes mellitus and non-diabetes mellitus among chronic kidney disease patients: A cross-sectional study of the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Oncotarget. 2017 Nov 10;8(63):106324-106332. doi: 10.18632/oncotarget.22368. eCollection 2017 Dec 5.</citation>
    <PMID>29290951</PMID>
  </results_reference>
  <results_reference>
    <citation>Lv L, Wang F, Wu L, Wang JW, Cui Z, Hayek SS, Wei C, Reiser J, He K, Zhang L, Chen M, Zhao MH. Soluble urokinase-type plasminogen activator receptor and incident end-stage renal disease in Chinese patients with chronic kidney disease. Nephrol Dial Transplant. 2020 Mar 1;35(3):465-470. doi: 10.1093/ndt/gfy265.</citation>
    <PMID>30124995</PMID>
  </results_reference>
  <results_reference>
    <citation>Lv L, Wang J, Gao B, Wu L, Wang F, Cui Z, He K, Zhang L, Chen M, Zhao MH. Serum uromodulin and progression of kidney disease in patients with chronic kidney disease. J Transl Med. 2018 Nov 19;16(1):316. doi: 10.1186/s12967-018-1693-2.</citation>
    <PMID>30454063</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuan Q, Wang J, Peng Z, Zhou Q, Xiao X, Xie Y, Wang W, Huang L, Tang W, Sun D, Zhang L, Wang F, Zhao MH, Tao L, He K, Xu H; C-STRIDE study group. Neutrophil-to-lymphocyte ratio and incident end-stage renal disease in Chinese patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Transl Med. 2019 Mar 15;17(1):86. doi: 10.1186/s12967-019-1808-4.</citation>
    <PMID>30876475</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu L, Li XQ, Chang DY, Zhang H, Li JJ, Wu SL, Zhang LX, Chen M, Zhao MH. Associations of urinary epidermal growth factor and monocyte chemotactic protein-1 with kidney involvement in patients with diabetic kidney disease. Nephrol Dial Transplant. 2020 Feb 1;35(2):291-297. doi: 10.1093/ndt/gfy314.</citation>
    <PMID>30357416</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu B, Wang Q, Wang Y, Wang J, Zhang L, Zhao M; C-STRIDE study group. Utilization of antihypertensive drugs among chronic kidney disease patients: Results from the Chinese cohort study of chronic kidney disease (C-STRIDE). J Clin Hypertens (Greenwich). 2020 Jan;22(1):57-64. doi: 10.1111/jch.13761. Epub 2019 Dec 9.</citation>
    <PMID>31816171</PMID>
  </results_reference>
  <results_reference>
    <citation>Pu L, Zou Y, Wu SK, Wang F, Zhang Y, Li GS, Wang JW, Zhang LX, Zhao MH, Wang L; C-STRIDE study group. Prevalence and associated factors of depressive symptoms among chronic kidney disease patients in China: Results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Psychosom Res. 2020 Jan;128:109869. doi: 10.1016/j.jpsychores.2019.109869. Epub 2019 Nov 13.</citation>
    <PMID>31739085</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen L, Wang J, Huang X, Wang F, Liang W, He Y, Liao Y, Zhang L, Zhao M, Xiong Z; C-STRIDE study group. Association between diabetes mellitus and health-related quality of life among patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Health Qual Life Outcomes. 2020 Aug 3;18(1):266. doi: 10.1186/s12955-020-01519-5.</citation>
    <PMID>32746855</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). White-coat hypertension and incident end-stage renal disease in patients with non-dialysis chronic kidney disease: results from the C-STRIDE Study. J Transl Med. 2020 Jun 15;18(1):238. doi: 10.1186/s12967-020-02413-w. Erratum In: J Transl Med. 2020 Jul 13;18(1):282.</citation>
    <PMID>32539728</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; C-STRIDE (Chinese Cohort Study of Chronic Kidney Disease)* dagger. Short-Term Systolic Blood Pressure Variability and Kidney Disease Progression in Patients With Chronic Kidney Disease: Results From C-STRIDE. J Am Heart Assoc. 2020 Jun 16;9(12):e015359. doi: 10.1161/JAHA.120.015359. Epub 2020 Jun 6.</citation>
    <PMID>32508195</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE); Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE) Collaborators. Nocturnal Systolic Hypertension and Adverse Prognosis in Patients with CKD. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):356-364. doi: 10.2215/CJN.14420920. Epub 2021 Feb 10.</citation>
    <PMID>33568382</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuan Q, Xie Y, Peng Z, Wang J, Zhou Q, Xiao X, Wang W, Huang L, Tang W, Li X, Zhang L, Wang F, Zhao MH, Tao L, He K, Wanggou S, Xu H; C-STRIDE study group. Urinary magnesium predicts risk of cardiovascular disease in Chronic Kidney Disease stage 1-4 patients. Clin Nutr. 2021 Apr;40(4):2394-2400. doi: 10.1016/j.clnu.2020.10.036. Epub 2020 Oct 23.</citation>
    <PMID>33160701</PMID>
  </results_reference>
  <results_reference>
    <citation>Shen Y, Wang J, Yuan J, Yang L, Yu F, Wang X, Zhao MH, Zhang L, Zha Y; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Anemia among Chinese patients with chronic kidney disease and its association with quality of life - results from the Chinese cohort study of chronic kidney disease (C-STRIDE). BMC Nephrol. 2021 Feb 22;22(1):64. doi: 10.1186/s12882-021-02247-8.</citation>
    <PMID>33618679</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang J, Liu L, He K, Gao B, Wang F, Zhao M, Zhang L, On Behalf Of The Chinese Cohort Study Of Chronic Kidney Disease C-Stride. UMOD Polymorphisms Associated with Kidney Function, Serum Uromodulin and Risk of Mortality among Patients with Chronic Kidney Disease, Results from the C-STRIDE Study. Genes (Basel). 2021 Oct 23;12(11):1687. doi: 10.3390/genes12111687.</citation>
    <PMID>34828293</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang J, Lv J, He K, Wang F, Gao B, Zhao MH, Zhang L. Longitudinal Follow-Up and Outcomes for Chinese Patients with Stage 1-4 Chronic Kidney Disease. Kidney Dis (Basel). 2021 Oct 27;8(1):72-81. doi: 10.1159/000519190. eCollection 2022 Jan.</citation>
    <PMID>35224008</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang J, Lv J, He K, Wang F, Gao B, Zhao MH, Zhang L; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Association of left ventricular hypertrophy and functional impairment with cardiovascular outcomes and mortality among patients with chronic kidney disease, results from the C-STRIDE study. Nephrology (Carlton). 2022 Apr;27(4):327-336. doi: 10.1111/nep.14009. Epub 2021 Dec 15.</citation>
    <PMID>34843156</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 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>Minghui Zhao</investigator_full_name>
    <investigator_title>Director of Renal Division, Department of Medicine</investigator_title>
  </responsible_party>
  <keyword>Cohort studies</keyword>
  <keyword>Prognosis</keyword>
  <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>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_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/NCT03041987
org study id: 2011BAI10B01
nct id: NCT03041987
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has dmc: Yes
This study aimed to explore underlying mechanisms of chronic kidney disease progression and
      its association with adverse consequences. It will enroll approximately 5000 pre-dialysis
      chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up
      for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and
      biomaterials will be collected at baseline and annually. The principal clinical outcomes of
      the study consist of renal disease events, cardiovascular events, and death.
The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms
      of chronic kidney disease progression and its association with adverse consequences. The
      study will establish a baseline cohort of 5000 Chinese pre-dialysis chronic kidney disease
      patients, who will be followed up until death or dropout or starting renal replacement
      therapy. The follow-up will be conducted for at least 5 years. Their clinical information and
      biomaterials will be collected at baseline and then annually during follow-up.

      The baseline visit includes the following items: detailed demographics; socioeconomic and
      health care services information; medical and family history; medication history; and
      questionnaires concerning quality of life, health behaviors, depressive and anxiety symptoms,
      cognitive function, and physical activity. Anthropometric measures (height, weight, waist
      circumference, hip circumference, resting blood pressure, heart rate, grip strength, and
      15-feet measured walk) will also be collected. The laboratory parameters of chemistry test,
      intact parathyroid hormone, 24-hour urine electrolytes, protein creatinine ratio, and albumin
      creatinine ratio should also be collected for each participant and measured in the central
      laboratory. After the baseline visit, participants will return annually for follow-up visits
      and evaluation. The evaluating items of follow-up visits are similar to the baseline visit,
      and sample collection.

      The principal clinical outcomes of the study can be broadly categorized as renal disease
      events, cardiovascular events, and death. Renal disease events include the incident end stage
      renal disease or significant loss of renal function.Cardiovascular events include acute
      myocardial infarction, unstable angina, hospitalization for congestive heart failure,
      incident serious cardiac arrhythmia, cerebrovascular events, and peripheral vascular
      diseases. Death is further clarified as cardiac, cerebrovascular, renal, others, or unknown.
observational model: Cohort
time perspective: Prospective
measure: End stage renal disease or significant loss of renal function
time frame: from date of baseline examination until the date of first documented end stage renal disease or significant loss of renal function or date of death from any cause, whichever came first, up to 60 months
description: start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2) or halving of estimated glomerular filtration rate or doubling of serum creatinine compared with the value of study entry
measure: Cardiovascular events
time frame: from date of baseline examination until the date of first documented cardiovascular events or date of death from any cause, whichever came first, up to 60 months
description: acute myocardial infarction, unstable angina, hospitalization for congestive heart failure, incident serious cardiac arrhythmia (resuscitated cardiac arrest, ventricular fibrillation, sustained ventricular tachycardia, paroxysmal ventricular tachycardia, an initial episode of atrial fibrillation or flutter, severe bradycardia or heart block), cerebrovascular events (intraparenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, cardioembolic cerebral infarction, etc.), and peripheral vascular diseases.
measure: Death
time frame: from date of baseline examination until the date of death from any cause, up to 60 months
description: death from any cause
arm group label: Chronic Kidney Disease
description: Specified estimated glomerular filtration rate (eGFR) range according to different CKD etiologies. For glomerular nephrology patients, the eGFR should be ≥15 ml/minute per 1.73m(2). For diabetic nephrology patients, the defining eligibility was 15 ml/minute per 1.73m(2)≤eGFR <60 ml/minute per 1.73m(2) or eGFR≥ 60 ml/minute per 1.73m(2) with "nephrotic range" proteinuria, which is defined as 24-hour urinary protein ≥3.5 g or urinary albumin creatinine ratio ≥2 000 mg/g or corresponding values of urine dipstick test or urinary protein creatinine ratio. For non-glomerular nephrology and non-diabetic nephrology patients, 15 ml/minute per 1.73m(2) ≤eGFR<60 ml/minute per 1.73m(2) is set for enrollment.
intervention type: Other
intervention name: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc
arm group label: Chronic Kidney Disease
Blood samples Urine samples DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
last name: Minghui Zhao, MD, Ph.D.
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Fang Wang, MD
phone: 011-86-10-83575535
email: wangfang@bjmu.edu.cn
last name: Yunfei Bao, MS
phone: 011-86-10-83575535
email: ckdcohort@163.com
facility: 
status: Recruiting
contact: 
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country: China
citation: Gao B, Zhang L, Wang H, Zhao M. Chinese cohort study of chronic kidney disease: design and methods. Chin Med J (Engl). 2014;127(11):2180-5.
PMID: 24902678
citation: Zhou C, Wang F, Wang JW, Zhang LX, Zhao MH. Mineral and Bone Disorder and Its Association with Cardiovascular Parameters in Chinese Patients with Chronic Kidney Disease. Chin Med J (Engl). 2016 Oct 5;129(19):2275-80. doi: 10.4103/0366-6999.190678.
PMID: 27647184
citation: Yuan J, Zou XR, Han SP, Cheng H, Wang L, Wang JW, Zhang LX, Zhao MH, Wang XQ; C-STRIDE study group. Prevalence and risk factors for cardiovascular disease among chronic kidney disease patients: results from the Chinese cohort study of chronic kidney disease (C-STRIDE). BMC Nephrol. 2017 Jan 14;18(1):23. doi: 10.1186/s12882-017-0441-9.
PMID: 28088175
citation: Peng Z, Wang J, Yuan Q, Xiao X, Xu H, Xie Y, Wang W, Huang L, Zhong Y, Ao X, Zhang L, Zhao M, Tao L, Zhou Q; C-STRIDE study group. Clinical features and CKD-related quality of life in patients with CKD G3a and CKD G3b in China: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). BMC Nephrol. 2017 Oct 13;18(1):311. doi: 10.1186/s12882-017-0725-0.
PMID: 29029600
citation: Yan Z, Wang Y, Li S, Wang J, Zhang L, Tan H, Li S, Yang L, Pei H, Zhang L, Wang Y, Duan J, Jiao S, Zhao M, Fu S; China National Survey of Chronic Kidney Disease Working Group. Hypertension Control in Adults With CKD in China: Baseline Results From the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Am J Hypertens. 2018 Mar 10;31(4):486-494. doi: 10.1093/ajh/hpx222.
PMID: 29304216
citation: Zhang JJ, Yang L, Huang JW, Liu YJ, Wang JW, Zhang LX, Zhao MH, Liu ZS. Characteristics and comparison between diabetes mellitus and non-diabetes mellitus among chronic kidney disease patients: A cross-sectional study of the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Oncotarget. 2017 Nov 10;8(63):106324-106332. doi: 10.18632/oncotarget.22368. eCollection 2017 Dec 5.
PMID: 29290951
citation: Lv L, Wang F, Wu L, Wang JW, Cui Z, Hayek SS, Wei C, Reiser J, He K, Zhang L, Chen M, Zhao MH. Soluble urokinase-type plasminogen activator receptor and incident end-stage renal disease in Chinese patients with chronic kidney disease. Nephrol Dial Transplant. 2020 Mar 1;35(3):465-470. doi: 10.1093/ndt/gfy265.
PMID: 30124995
citation: Lv L, Wang J, Gao B, Wu L, Wang F, Cui Z, He K, Zhang L, Chen M, Zhao MH. Serum uromodulin and progression of kidney disease in patients with chronic kidney disease. J Transl Med. 2018 Nov 19;16(1):316. doi: 10.1186/s12967-018-1693-2.
PMID: 30454063
citation: Yuan Q, Wang J, Peng Z, Zhou Q, Xiao X, Xie Y, Wang W, Huang L, Tang W, Sun D, Zhang L, Wang F, Zhao MH, Tao L, He K, Xu H; C-STRIDE study group. Neutrophil-to-lymphocyte ratio and incident end-stage renal disease in Chinese patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Transl Med. 2019 Mar 15;17(1):86. doi: 10.1186/s12967-019-1808-4.
PMID: 30876475
citation: Wu L, Li XQ, Chang DY, Zhang H, Li JJ, Wu SL, Zhang LX, Chen M, Zhao MH. Associations of urinary epidermal growth factor and monocyte chemotactic protein-1 with kidney involvement in patients with diabetic kidney disease. Nephrol Dial Transplant. 2020 Feb 1;35(2):291-297. doi: 10.1093/ndt/gfy314.
PMID: 30357416
citation: Liu B, Wang Q, Wang Y, Wang J, Zhang L, Zhao M; C-STRIDE study group. Utilization of antihypertensive drugs among chronic kidney disease patients: Results from the Chinese cohort study of chronic kidney disease (C-STRIDE). J Clin Hypertens (Greenwich). 2020 Jan;22(1):57-64. doi: 10.1111/jch.13761. Epub 2019 Dec 9.
PMID: 31816171
citation: Pu L, Zou Y, Wu SK, Wang F, Zhang Y, Li GS, Wang JW, Zhang LX, Zhao MH, Wang L; C-STRIDE study group. Prevalence and associated factors of depressive symptoms among chronic kidney disease patients in China: Results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Psychosom Res. 2020 Jan;128:109869. doi: 10.1016/j.jpsychores.2019.109869. Epub 2019 Nov 13.
PMID: 31739085
citation: Chen L, Wang J, Huang X, Wang F, Liang W, He Y, Liao Y, Zhang L, Zhao M, Xiong Z; C-STRIDE study group. Association between diabetes mellitus and health-related quality of life among patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Health Qual Life Outcomes. 2020 Aug 3;18(1):266. doi: 10.1186/s12955-020-01519-5.
PMID: 32746855
citation: Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). White-coat hypertension and incident end-stage renal disease in patients with non-dialysis chronic kidney disease: results from the C-STRIDE Study. J Transl Med. 2020 Jun 15;18(1):238. doi: 10.1186/s12967-020-02413-w. Erratum In: J Transl Med. 2020 Jul 13;18(1):282.
PMID: 32539728
citation: Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; C-STRIDE (Chinese Cohort Study of Chronic Kidney Disease)* dagger. Short-Term Systolic Blood Pressure Variability and Kidney Disease Progression in Patients With Chronic Kidney Disease: Results From C-STRIDE. J Am Heart Assoc. 2020 Jun 16;9(12):e015359. doi: 10.1161/JAHA.120.015359. Epub 2020 Jun 6.
PMID: 32508195
citation: Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE); Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE) Collaborators. Nocturnal Systolic Hypertension and Adverse Prognosis in Patients with CKD. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):356-364. doi: 10.2215/CJN.14420920. Epub 2021 Feb 10.
PMID: 33568382
citation: Yuan Q, Xie Y, Peng Z, Wang J, Zhou Q, Xiao X, Wang W, Huang L, Tang W, Li X, Zhang L, Wang F, Zhao MH, Tao L, He K, Wanggou S, Xu H; C-STRIDE study group. Urinary magnesium predicts risk of cardiovascular disease in Chronic Kidney Disease stage 1-4 patients. Clin Nutr. 2021 Apr;40(4):2394-2400. doi: 10.1016/j.clnu.2020.10.036. Epub 2020 Oct 23.
PMID: 33160701
citation: Shen Y, Wang J, Yuan J, Yang L, Yu F, Wang X, Zhao MH, Zhang L, Zha Y; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Anemia among Chinese patients with chronic kidney disease and its association with quality of life - results from the Chinese cohort study of chronic kidney disease (C-STRIDE). BMC Nephrol. 2021 Feb 22;22(1):64. doi: 10.1186/s12882-021-02247-8.
PMID: 33618679
citation: Wang J, Liu L, He K, Gao B, Wang F, Zhao M, Zhang L, On Behalf Of The Chinese Cohort Study Of Chronic Kidney Disease C-Stride. UMOD Polymorphisms Associated with Kidney Function, Serum Uromodulin and Risk of Mortality among Patients with Chronic Kidney Disease, Results from the C-STRIDE Study. Genes (Basel). 2021 Oct 23;12(11):1687. doi: 10.3390/genes12111687.
PMID: 34828293
citation: Wang J, Lv J, He K, Wang F, Gao B, Zhao MH, Zhang L. Longitudinal Follow-Up and Outcomes for Chinese Patients with Stage 1-4 Chronic Kidney Disease. Kidney Dis (Basel). 2021 Oct 27;8(1):72-81. doi: 10.1159/000519190. eCollection 2022 Jan.
PMID: 35224008
citation: Wang J, Lv J, He K, Wang F, Gao B, Zhao MH, Zhang L; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Association of left ventricular hypertrophy and functional impairment with cardiovascular outcomes and mortality among patients with chronic kidney disease, results from the C-STRIDE study. Nephrology (Carlton). 2022 Apr;27(4):327-336. doi: 10.1111/nep.14009. Epub 2021 Dec 15.
PMID: 34843156
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Minghui Zhao
investigator title: Director of Renal Division, Department of Medicine
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
sharing ipd: Undecided