Chinese Cohort Study of Chronic Kidney Disease

NCT ID: NCT03041987

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Insufficiency, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Boai Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

the Affiliated Hospital of Hubei Traditional Chinese Medical College

UNKNOWN

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Chifeng Second Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of BaoTou Medical College

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Minhang Central Hospital

UNKNOWN

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Second Hospital

OTHER

Sponsor Role collaborator

the First Affiliated Hospital of the Medical College of Shihezi University

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Yuxi City People's Hospital

UNKNOWN

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Minghui Zhao

Director of Renal Division, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minghui Zhao, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 35755057 (View on PubMed)

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.

Reference Type RESULT
PMID: 36836039 (View on PubMed)

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.

Reference Type RESULT
PMID: 37799589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24902678 (View on PubMed)

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.

Reference Type RESULT
PMID: 27647184 (View on PubMed)

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.

Reference Type RESULT
PMID: 28088175 (View on PubMed)

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.

Reference Type RESULT
PMID: 29029600 (View on PubMed)

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.

Reference Type RESULT
PMID: 29304216 (View on PubMed)

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.

Reference Type RESULT
PMID: 29290951 (View on PubMed)

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.

Reference Type RESULT
PMID: 30124995 (View on PubMed)

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.

Reference Type RESULT
PMID: 30454063 (View on PubMed)

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.

Reference Type RESULT
PMID: 30876475 (View on PubMed)

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.

Reference Type RESULT
PMID: 30357416 (View on PubMed)

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.

Reference Type RESULT
PMID: 31816171 (View on PubMed)

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.

Reference Type RESULT
PMID: 31739085 (View on PubMed)

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.

Reference Type RESULT
PMID: 32746855 (View on PubMed)

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.

Reference Type RESULT
PMID: 32539728 (View on PubMed)

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.

Reference Type RESULT
PMID: 32508195 (View on PubMed)

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.

Reference Type RESULT
PMID: 33568382 (View on PubMed)

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.

Reference Type RESULT
PMID: 33160701 (View on PubMed)

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.

Reference Type RESULT
PMID: 33618679 (View on PubMed)

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.

Reference Type RESULT
PMID: 34828293 (View on PubMed)

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.

Reference Type RESULT
PMID: 35224008 (View on PubMed)

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.

Reference Type RESULT
PMID: 34843156 (View on PubMed)

Other Identifiers

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2011BAI10B01

Identifier Type: -

Identifier Source: org_study_id

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