jRCT2011230055进行中（未招募）不适用
Phase IIa clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 26age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Patients diagnosed as ADPKD by modified Pei-Ravine
- •eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m^2
- •Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
- •Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg.
排除标准
- •Women who are pregnant or may be pregnant
- •Nursing mother
- •Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:
- •Female: From informed consent to 2 years after the last administration of the study drug
- •Male: From informed consent to 6 months after the last administration of the study drug
- •Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug
- •Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function
结局指标
主要结局
-
efficacy
次要结局
未报告次要终点
研究者
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