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临床试验/NCT04229485
NCT04229485Unknown不适用

The Chinese Cohort Study of Chronic Kidney Disease Patients Followed on Smartphone Platform, a Multi-center Observational Study

Limeng Chen1 个研究点 分布在 1 个国家目标入组 3,360 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,360
试验地点
1
主要终点
incidence of progression to ESRD

研究概览

简要总结

This is a multi-center prospective cohort study. The purpose of this study is to investigate the relationship between bone metabolic markers and other non-traditional risk factors with kidney function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. In the meantime, this study is to explore a new mode of management and complication monitoring through mobile communication in chronic kidney disease patients.

详细描述

Abnormal mineral bone metabolism of chronic kidney disease (CKD-MBD) is the most common complication of CKD. It involves kidney, bone metabolism, parathyroid gland, cardiovascular and cerebrovascular organs. It is an independent risk factor for progression of CKD to end-stage renal disease (ESRD), vascular and cardiac valve calcification, and cardiovascular and cerebrovascular events. However, less data concerning the relationship between bone metabolic index, such as high blood phosphorus and cardiovascular diseases, bone mass reduction and fracture is available in Chinese adult patients. This study is a multi-center prospective cohort study to explore the relationship between bone metabolic markers and other non-traditional risk factors with renal function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. Based on the sample size estimation, 3360 subjects should be enrolled in this study. The primary outcome is progression to ESRD (start dialysis or kidney transplantation) or doubling of serum creatinine, as well as cardiovascular events and all-cause mortality.

At present, the follow-up and the management of complications of CKD patients are not enough. The popularity of mobile communication in China provide the possibility to strengthen the follow-up and complications management in CKD patients and save human resources. This study is to explore a new mode of collecting datas through mobile communication in chronic kidney disease patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least two measurements of serum Cr (with a minimum interval of 3 months), , 10≤eGFR≤60ml/min/1.73m^2

排除标准

  • Unable or unwilling to provide informed consent
  • Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis (HBV or HCV) services
  • Acute mycardial infarction within the last six months
  • NYHA Class III or IV heart failure at baseline
  • Ongoing chemotherapy or immunosuppressive therapy (in the preceding 6 months to treat renal or immune disease)
  • Current renal replacement therapy
  • Current pregnancy or breastfeeding women
  • Any organ transplantation
  • Currently participation in an interventional clinical trial

结局指标

主要结局

incidence of progression to ESRD

时间窗: 2 year

begin to dialysis and kidney transplantation

cardiovascular event and all-cause mortality

时间窗: 2 year

diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage

次要结局

  • the rate of eGFR decline(2 years)
  • bone mass change(2 years)
  • Kidney Disease Outcomes Quality Initiative-Short Form 36(2 years)
  • frailty(2 years)
  • the way of dialysis initiation(2 years)

研究者

发起方
Limeng Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Limeng Chen

Professor of Medicine, Associate Chief of Nephrology Division

Peking Union Medical College Hospital

研究点 (1)

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