The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of FMD(Flow Mediated Dilatation)
研究概览
简要总结
Indoxyl sulfate (IS) is a uremic toxin that accelerates the progression of chronic kidney disease (CKD). AST-120 (Kremezin®; Kureha Corporation, Tokyo, Japan) removes indole, which is the precursor of IS, in the intestine, and reduces the accumulation of IS. This drug has been shown to retard the deterioration of renal function in CKD patients through reducing the levels of IS.
IS was reported to promote aortic calcification and stimulate the proliferation of vascular smooth muscle cells (VSMC). IS also inhibits endothelial proliferation and wound repair. With this background, the investigators will performed the study whether AST-120 improve the endothelial dysfunction in CKD patients.
详细描述
The purpose of this study is to examine whether Kremezin, Indoxyl sulfate lowering agent improve endothelial dysfunction in stage 3,4 chronic kidney disease patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Chronic kidney disease (Stage3 - Stage4)
- •Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
排除标准
- •Acute gastric or duodenal ulcer
- •Severe constipation
研究组 & 干预措施
AST-120
AST-120 administration 2g three times a day
干预措施: Kremezin (Drug)
结局指标
主要结局
Changes of FMD(Flow Mediated Dilatation)
时间窗: 6 months
FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.
次要结局
- Level of Indoxyl Sulfate(3 months, 6 months)