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临床试验/NCT00563355
NCT00563355已完成不适用

A Prospective Randomised Controlled Trial to Study the Effects of Recombinant Human Erythropoietin on the Progression of Atherosclerosis, Cardiovascular Function, Nutrition and Residual Renal Function in Pre-dialysis Chronic Renal Failure Patients

Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2001年2月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
endothelial function and atherosclerosis

研究概览

简要总结

The primary aim of the study is to evaluate the effects of correction of anemia using erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in patients with chronic kidney disease

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic renal failure with serum creatinine between 150umol/L and 800umol/L and at the same time Hb
  • Patients with regression line of 1/serum creatinine versus time showing that they may not require dialysis within the coming 12 months
  • Patients below the age of 75

排除标准

  • Patients with valvular heart disease/congenital heart disease
  • Patients with ischemic heart disease/history of myocardial infarction/coronary artery bypass surgery
  • Patients with history of heart failure
  • Patients with regression line of 1/serum creatinine versus time showing that the estimated date of end stage renal disease is within 12 months
  • Patients with thalassemic trait or haemoglobinopathies
  • Patients with underlying haematological malignancies
  • Patients with active bleeding
  • Patients with uncorrected iron or other vitamins deficiencies
  • Patients with poor general condition

结局指标

主要结局

endothelial function and atherosclerosis

时间窗: 6 month, 1 year

cardiac hypertrophy and cardiac function

时间窗: 6 month, 1 year

次要结局

  • nutrition status(6 month, 1 year)
  • residual renal function(6 month, 1 year)
  • quality of life(6 month, 1 year)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov

研究点 (1)

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