Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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 outcome measure(s)
End stage renal disease or significant loss of renal function — 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 — 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 — from date of baseline examination until the date of death from any cause, up to 60 months death from any cause
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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