KNOW-CKD（韩国慢性肾脏病患者结局队列研究）：设计与方法。

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

机构信息

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

出版信息

BMC Nephrol. 2014 May 19;15:80. doi: 10.1186/1471-2369-15-80.

DOI:10.1186/1471-2369-15-80

PMID:24884708

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4050398/

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.

摘要

背景

慢性肾脏病的进展和并发症应因病因（C）、肾小球滤过率类别（G）和白蛋白尿（A）而异。 KNOW-CKD（韩国慢性肾脏病患者结局队列研究）是一项前瞻性队列研究，纳入了 1 至 5 期慢性肾脏病（透析前）患者。

方法/设计：韩国 9 个主要大学医院的肾病中心将在 2011 年至 2015 年期间，用 5 年时间招募约 2450 名慢性肾脏病成人患者。这些参与者将被监测约 10 年，直至死亡或发生终末期肾病。根据慢性肾脏病的具体病因（肾小球肾炎、糖尿病肾病、高血压肾病、多囊肾病等）将患者分为亚组。符合条件的患者将在基线时进行社会人口统计学信息、详细的个人/家族史、办公室血压、生活质量和健康行为评估。研究入组后，将按照标准化方案进行全面评估，包括实验室检查、心脏评估和影像学检查。定期采集生物标本样本。肾脏事件定义为 eGFR（估算肾小球滤过率）较基线值下降>50%、血清肌酐加倍或终末期肾病。主要复合结局包括肾脏事件、心血管事件和死亡。截至 2013 年 9 月，该研究已纳入 1470 名成年慢性肾脏病患者，其中肾小球肾炎 543 例、糖尿病肾病 317 例、高血压肾病 294 例、多囊肾病 249 例。