KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods.

Kook-Hwan Oh,Sun Woo Kang,Seung Hyeok Han,Yeong Hoon Kim,Curie Ahn,Yong-Soo Kim,Kyu Hun Choi,Kyubeck Lee,Wookyung Chung,Ho Jun Chin,Tae Hyun Yoo,Soo Wan Kim,Dong Wan Chae,Byung-Joo Park,Young-Hwan Hwang,Sue Kyung Park,Hayne Cho Park,Joongyub Lee

doi:10.1186/1471-2369-15-80

Abstract

BackgroundThe 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/DesignNine 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.DiscussionAs 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 registrationNo. NCT01630486 at http://www.clinicaltrials.gov.

Highlights

The progression and complications of chronic kidney disease should differ depending on the cause (C), glomerular filtration rate category (G), and albuminuria (A)
The incidence or mortality rates according to each outcome variable will be calculated for each etiologic group; the incidence ratios will be presented with reference to the diabetic nephropathy subgroup
The Chronic kidney disease (CKD) progression will be evaluated using decreased GFR calculations. Because it is common for a patient with CKD to have a non-linear decline in GFR or a prolonged period of non-progression [20], we will assess the longitudinal trajectory of GFR for the individual

Summary

Introduction

The progression and complications of chronic kidney disease should differ depending on the cause (C), glomerular filtration rate category (G), and albuminuria (A). Since 2002, a large number of epidemiologic studies, in addition to the general population, have demonstrated a significantly increased risk of adverse consequences in subjects with albuminuria, even in the presence of normal or mildly decreased GFR [4,5]. This finding warrants a broader view of the early stages of CKD within the nephrology population to determine the variables associated with CKD and the increased risks of death and adverse outcomes [6]. The mechanistic link between albuminuria and adverse consequences has not been established

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Discussion

Conclusion