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KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods
Kook-Hwan Oh, Sue Kyung Park, Hayne Cho Park
1Department of Internal Medicine, Seoul National University, 101 Daehakro, Chongno Gu, Seoul 110-744, Korea. curie@snu.ac.kr.
Insights
The KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease (KNOW-CKD) tracks over 1,400 patients to understand chronic kidney disease progression and outcomes in Asian populations. This research clarifies natural disease courses and risk factors.
Area of Science:
- Nephrology
- Epidemiology
- Clinical Research
Background:
- Chronic kidney disease (CKD) progression and complications vary by cause, glomerular filtration rate (GFR) category, and albuminuria.
- The KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease (KNOW-CKD) is a prospective study of predialysis CKD patients.
Purpose of the Study:
- To clarify the natural course, complication profiles, and risk factors of chronic kidney disease in Asian populations.
- To establish and maintain the first large-scale CKD cohort study in Asia for up to 10 years.
Main Methods:
- Enrollment of approximately 2,450 adults with CKD stages 1-5 across nine Korean nephrology centers from 2011-2015.
- Longitudinal monitoring for up to 10 years, with classification by CKD cause (glomerulonephritis, diabetic nephropathy, etc.).
- Comprehensive baseline evaluations and regular assessments including laboratory tests, cardiac evaluation, imaging, and biospecimen collection. Renal events defined by eGFR decrease, creatinine doubling, or ESRD. Primary outcome: renal events, cardiovascular events, and death.
Main Results:
- As of September 2013, 1,470 adult CKD subjects were enrolled.
- Subgroup enrollment included 543 with glomerulonephritis, 317 with diabetic nephropathy, 294 with hypertensive nephropathy, and 249 with polycystic kidney disease.
Conclusions:
- The KNOW-CKD study is the first large-scale, longitudinal CKD cohort in Asia.
- It will provide crucial insights into the natural history, complications, and risk factors specific to Asian CKD patients.
Background:
The progression and complications of chronic kidney disease should differ depending on the cause (C), glomerular filtration rate category (G), and albuminuria (A). The KNOW-CKD (KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease), which is a prospective cohort study, enrolls subjects with chronic kidney disease stages 1 to 5 (predialysis).
Methods/Design:
Nine nephrology centers in major university hospitals throughout Korea will enroll approximately 2,450 adults with chronic kidney disease over a 5-year period from 2011 to 2015. The participating individuals will be monitored for approximately 10 years until death or until end-stage renal disease occurs. The subjects will be classified into subgroups based on the following specific causes of chronic kidney disease: glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, polycystic kidney disease, and others. The eligible subjects will be evaluated at baseline for socio-demographic information, detailed personal/family history, office BP, quality of life, and health behaviors. After enrollment in the study, thorough assessments, including laboratory tests, cardiac evaluation and radiologic imaging, will be performed according to the standardized protocol. The biospecimen samples will be collected regularly. A renal event is defined by >50% decrease in estimated GFR (eGFR) from the baseline values, doubling of serum creatinine, or end-stage renal disease. The primary composite outcome consists of renal events, cardiovascular events, and death. As of September 2013, 1,470 adult chronic kidney disease subjects were enrolled in the study, including 543 subjects with glomerulonephritis, 317 with diabetic nephropathy, 294 with hypertensive nephropathy and 249 with polycystic kidney disease.
Discussion:
As the first large-scale chronic kidney disease cohort study to be established and maintained longitudinally for up to 10 years, the KNOW-CKD will help to clarify the natural course, complication profiles, and risk factors of Asian populations with chronic kidney disease.
Trial Registration:
No. NCT01630486 at http://www.clinicaltrials.gov.
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