Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE)
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|ClinicalTrials.gov Identifier: NCT03041987|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment|
|Renal Insufficiency, Chronic||Other: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc|
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.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Chinese Cohort Study of Chronic Kidney Disease|
|Actual Study Start Date :||January 1, 2012|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2026|
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|
- 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 ]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
- 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 ]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.
- Death [ Time Frame: from date of baseline examination until the date of death from any cause, up to 60 months ]death from any cause
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041987
|Contact: Fang Wang, MDfirstname.lastname@example.org|
|Contact: Yunfei Bao, MSemail@example.com|
|Peking University First Hospital||Recruiting|
|Beijing, Beijing, China, 100034|
|Contact: Yunfei Bao, MS 011-86-10-83575535 firstname.lastname@example.org|
|Principal Investigator: Luxia Zhang, MD, MPH|
|Principal Investigator:||Minghui Zhao, MD, Ph.D.||Peking University First Hospital|