Chinese Cohort Study of Chronic Kidney Disease

Renal Insufficiency, Chronic Clinical Trial

— C-STRIDE  

Official title:

Chinese Cohort Study of Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03041987
• Other study ID #: 2011BAI10B01
• Status: Active, not recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (39)

Lead Sponsor

Collaborator

Peking University First Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (24)

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 St — View Citation

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 20 — View 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. — View Citation

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 — View 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). 20 — View 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 Transpl — View 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. — View 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 Co — View 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 — View 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 — View 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 Di — View 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. — View 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 ki — View 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 — View 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 Tran — View 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 — View 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 — View Citation

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-STRID — View 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 Chi — View 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 disea — View 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 d — View 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 patie — View 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 Chroni — View 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Death	death from any cause	from date of baseline examination until the date of death from any cause, up to 60 months