跳至主要内容
临床试验/NCT03929900
NCT03929900招募中不适用

KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease: A Longitudinal Cohort Study of the Chronic Kidney Disease (KNOW-CKD), Phase II Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
1
主要终点
Overall mortality

研究概览

简要总结

The goals of KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence. KNOW-CKD Phase I has enrolled 2,238 patients and these patients were divided into four major subgroups depending on the specific causes of CKD : glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, and polycystic kidney disease. In progress, renal progression, complications, and cardiovascular disease of these patients are followed up now.

Since there was a lack of information related to patients' lifestyle, it is necessary to conduct various studies that can be applied to actual clinical status through evaluation of nutrition, cognitive functions, and lifestyles of patients with CKD in South Korea. In addition, researches for high risk patients including diabetic nephropathy, advanced CKD and elderly patients are needed. Thus, KNOW-CKD phase II will enroll the CKD subjects at a more advanced-stage, and older patients than KNOW-CKD phase I subjects.

KNOW-CKD phase II Investigator Group comprises nephrologists, epidemiologists and statisticians from multi-centers in South Korea. KNOW-CKD phase II will enroll 1,500 individuals with estimated glomerular filtration rate between 20 and 60mL/min/1.73m2 (CKD-EPI[Cr] equation) between 2019 and 2021 and follow them until 2016 (for 5~7 years). Unlike phase I, patients diagnosed with glomerulonephritis and ADPKD will be excluded in Phase II.

详细描述

At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, and anemia. Nutritional evaluation through skin fold, hand grip test, bioelectrical impedence analysis, and 7-point subjective global assessment (SGA), food frequency questionnaire (FFQ) will be conducted in a subgroup of patients. Information on the medical history, health questionnaires, QOL, K-MoCA will also be collected. Web-based case-report forms (CRF) will be used for the systematic management of the patient data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45-79 years
  • Estimated glomerular filtration rate 20-60mL/min/1.73m2 based on CKD-EPI(Cr) equation
  • Non-dialysis dependent (NDD)

排除标准

  • Autosomal dominant polycystic kidney disease
  • Unable or unwilling to give consent
  • Previously received chronic dialysis
  • Previous any organ transplant
  • Patients who diagnosed heart failure with NYHA class 3 or 4
  • Known liver cirrhosis (Child-pugh class 2 or 3)
  • Pregnant women
  • Single kidney due to trauma or donation
  • Patients who received immunosuppressive agent within the past 1 year
  • Patients who diagnosed with glomerulonephritis through kidney biopsy

结局指标

主要结局

Overall mortality

时间窗: 5 years

all-cause death, cardiovascular death

次要结局

  • Renal replacement therapy(5 years)
  • Doubling of serum creatinine or eGFR halving(5 years)
  • Cardiovascular event(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kook-Hwan Oh

Professor

Seoul National University Hospital

研究点 (1)

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