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Open Access Study protocol

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

Kook-Hwan Oh1, Sue Kyung Park2, Hayne Cho Park1, Ho Jun Chin1, Dong Wan Chae1, Kyu Hun Choi3, Seung Hyeok Han3, Tae Hyun Yoo3, Kyubeck Lee4, Yong-Soo Kim5, Wookyung Chung6, Young-Hwan Hwang7, Soo Wan Kim8, Yeong Hoon Kim9, Sun Woo Kang9, Byung-Joo Park2, Joongyub Lee10, Curie Ahn1* and Representing KNOW-CKD Study Group

Author Affiliations

1 Department of Internal Medicine, Seoul National University, 101 Daehakro, Chongno Gu, Seoul 110-744, Korea

2 Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea

3 Department of Internal Medicine, Yonsei University, Severance Hospital, Seoul, Korea

4 Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University, Seoul, Korea

5 Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea

6 Department of Internal Medicine, Gachon University, Gil Hospital, Incheon, Korea

7 Department of Internal Medicine, Eulji University, Eulji General Hospital, Seoul, Korea

8 Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea

9 Department of Internal Medicine, Inje University, Pusan Paik Hospital, Busan, Korea

10 Medical Research Collaborating Center, Seoul National University Hospital and Seoul National University College of Medicine, Seoul, Korea

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BMC Nephrology 2014, 15:80  doi:10.1186/1471-2369-15-80

Published: 19 May 2014

Abstract

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 webcite.

Keywords:
KNOW-CKD; Chronic kidney disease; Cohort; Etiology; Progression; Complication; Natural course