Clinical trial NCT03041987: Chinese Cohort Study of Chronic Kidney Disease
Official title: Chinese Cohort Study of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Insufficiency, Chronic
Keywords: Cohort studies
Prognosis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Dongzhimen Hospital, Beijing
name: Beijing Hospital
name: Beijing Boai Hospital
name: Peking University Shenzhen Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Guizhou Provincial People's Hospital
name: First Affiliated Hospital of Chengdu Medical College
name: Affiliated Hospital of Hebei University
name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: the Affiliated Hospital of Hubei Traditional Chinese Medical College
name: Xiangya Hospital of Central South University
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Dalian Medical University
name: Chifeng Second Hospital
name: The First Affiliated Hospital of BaoTou Medical College
name: Qilu Hospital of Shandong University
name: Shandong Provincial Hospital
name: Qianfoshan Hospital
name: Second Hospital of Shanxi Medical University
name: Minhang Central Hospital
name: West China Hospital
name: Sichuan Provincial People's Hospital
name: Tianjin Medical University General Hospital
name: Tianjin Medical University Second Hospital
name: the First Affiliated Hospital of the Medical College of Shihezi University
name: First Affiliated Hospital of Xinjiang Medical University
name: The Second Affiliated Hospital of Kunming Medical University
name: Yuxi City People's Hospital
name: Zhejiang University
name: Xinqiao Hospital of Chongqing
name: The Second Affiliated Hospital of Chongqing Medical University
name: First Affiliated Hospital of Chongqing Medical University
name: The Second Hospital of Anhui Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: General Hospital of Ningxia Medical University
name: Shengjing Hospital
First posted: 2017-02-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: End stage renal disease or significant loss of renal function
timeFrame: 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
measure: Cardiovascular events
timeFrame: 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
measure: Death
timeFrame: from date of baseline examination until the date of death from any cause, up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Minghui Zhao, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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: 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: 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: 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: 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.
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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.
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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.
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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.
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