NCT02681991已完成4 期
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- change from baseline of Indoxyl sulfate at 8weeks
研究概览
简要总结
Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.
120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).
Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients spontaneously written consent to participate in this clinical trial
- •men and women over age of 19
- •pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
- •patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)
排除标准
- •patients with passes through the digestive tract disorders
- •patients with uncontrolled constipation symptoms
- •patients suffering from digestive tract ulcers and esophageal varices
- •patients with untreated severe hypertension (DBP ≥ 120mmHg)
- •patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
- •patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
- •subjects with dependency on alcohol
- •patients with current infections
- •pregnant women, nursing mothers
- •Patients with a possibility of pregnancy (However, negative case can be registered)
- •patients participating in another clinical trial in addition to the current clinical trial
- •Patient who do not fit the clinical trial participation the legal and mentally
研究组 & 干预措施
test
Experimental
Renamezin capsule 2g, tid, PO
干预措施: Renamezin capsule (Drug)
结局指标
主要结局
change from baseline of Indoxyl sulfate at 8weeks
时间窗: 0, 8weeks
次要结局
未报告次要终点
研究者
Hyeong-Cheon Park
Principal Investigator
Gangnam Severance Hospital
研究点 (1)
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