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临床试验/NCT03427944
NCT03427944Unknown4 期

the Effect of Calcium Dobesilate on Non Dialysis Patients With Chronic Renal Failure

The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
glomerular filtration rate

研究概览

简要总结

To investigate the feasibility of calcium dobesilate in the treatment of microvascular injury provides new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

详细描述

The deterioration of renal function is closely related to microvascular damage, calcium dobesilate is known as microcirculation protective agent, the investigators will further study its effect of non dialysis patients with chronic renal failure and explore the feasibility of calcium dobesilate in treatment of renal microvascular injury, the investigators will provide new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enroll the non dialysis patients with chronic renal failure hospitalized in the Department of Nephrology of the Affiliated Hospital of Xuzhou Medical University.
  • According to the glomerular filtration rate, the patients who were not required to be dialysate were at CKD3-5 (GFR between 10 and 59ml/min).

排除标准

  • Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
  • Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).

研究组 & 干预措施

Calcium Dobesilate group

Active Comparator

Calcium dobesilate group was treated with calcium dobesilate (500mg, tid , po), its conservative treatment was the same as that of the conventional treatment group

干预措施: Calcium Dobesilate group (Drug)

Conventional Treatment group

Placebo Comparator

conventional treatment group was treated with conventional conservative treatment of renal failure (low protein, low salt, low fat, low phosphorus diet, balance the internal environment; control blood pressure ; remove intestinal toxins etc.)

干预措施: Conventional Treatment group (Drug)

结局指标

主要结局

glomerular filtration rate

时间窗: up to 6 months

emission computed tomography

次要结局

  • serum creatinine(up to 6 months)
  • Cystatin C(up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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