Chinese Cohort Study of Chronic Kidney Disease

NCT03041987 | Active Not Recruiting DMC

• 1 other identifier: 2011BAI10B01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Insufficiency, Chronic

Keywords

Cohort studies; Prognosis

Outcome Measures

Primary Outcomes (3)

• End stage renal disease or significant loss of renal function

  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

  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

• Cardiovascular events

  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.

  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

• Death

  death from any cause

  from date of baseline examination until the date of death from any cause, up to 60 months

Study Arms (1)

Chronic Kidney Disease

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.

Other: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc

Interventions

Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc OTHER

Chronic Kidney Disease

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study enrolled chronic kidney disease patients with a broad spectrum of renal diseases with various severities and phenotypes.

You may qualify if:

• Participants should meet the following criteria of enrollment according to their etiology of nephrology.
• For glomerular nephrology patients, the estimated glomerular filtration rate (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 (ACR) ≥2 000 mg/g or corresponding values of urine dipstick test or urinary protein creatinine ratio (PCR).
• 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.

You may not qualify if:

• Participants meeting even one of the listed items should be excluded.
• NYHA Class III or IV heart failure.
• Chronic kidney disease caused by systemic inflammatory illness or autoimmune disease, such as lupus erythematosus.
• Treated with immunosuppressive agents in the preceding 6 months to treat renal or immune disease.
• Self-reported or known diagnosis of HIV infection and/or AIDS.
• Isolated hematuria.
• Self-reported or known diagnosis of cirrhosis.
• Pregnant or breast-feeding women.
• Malignancy treated with chemotherapy within last 2 years.
• Renal or other transplantation.
• Hereditary kidney disease.
• Participation in interventional clinical trial.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• Beijing Hospital: collaborator
• Beijing Boai Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Guizhou Provincial People's Hospital: collaborator
• First Affiliated Hospital of Chengdu Medical College: collaborator
• Affiliated Hospital of Hebei University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• the Affiliated Hospital of Hubei Traditional Chinese Medical College: collaborator
• Xiangya Hospital of Central South University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Chifeng Second Hospital: collaborator
• The First Affiliated Hospital of BaoTou Medical College: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shandong Provincial Hospital: collaborator
• Qianfoshan Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Minhang Central Hospital: collaborator
• West China Hospital: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• the First Affiliated Hospital of the Medical College of Shihezi University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• Yuxi City People's Hospital: collaborator
• Zhejiang University: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Shengjing Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (24)

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 32539728 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Deng X, Gao B, Wang F, Zhao MH, Wang J, Zhang L. Red Blood Cell Distribution Width Is Associated With Adverse Kidney Outcomes in Patients With Chronic Kidney Disease. Front Med (Lausanne). 2022 Jun 9;9:877220. doi: 10.3389/fmed.2022.877220. eCollection 2022.

  PMID: 35755057 RESULT

• Hui M, Ma J, Yang H, Gao B, Wang F, Wang J, Lv J, Zhang L, Yang L, Zhao M. ESKD Risk Prediction Model in a Multicenter Chronic Kidney Disease Cohort in China: A Derivation, Validation, and Comparison Study. J Clin Med. 2023 Feb 14;12(4):1504. doi: 10.3390/jcm12041504.

  PMID: 36836039 RESULT

• Xue X, Li JX, Wang JW, Lin LM, Cheng H, Deng DF, Xu WC, Zhao Y, Zou XR, Yuan J, Zhang LX, Zhao MH, Wang XQ. Association between alkaline phosphatase/albumin ratio and the prognosis in patients with chronic kidney disease stages 1-4: results from a C-STRIDE prospective cohort study. Front Med (Lausanne). 2023 Sep 20;10:1215318. doi: 10.3389/fmed.2023.1215318. eCollection 2023.

  PMID: 37799589 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Urine samples DNA

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Demography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Minghui Zhao, MD, Ph.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Renal Division, Department of Medicine

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)