JPRN-jRCT2011230055尚未招募2 期
Phase IIa clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Hayashi Ayuto0 个研究点目标入组 70 人开始时间: 2023年12月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 26age old 至 <= 55age old（—）
- 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. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent
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:
- •1) Female: From informed consent to 2 years after the last administration of the study drug
- •2) 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
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