NCT06289998进行中（未招募）2 期
Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Changes in TKV from baseline
研究概览
简要总结
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 26 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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:
- •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
研究组 & 干预措施
Tamibarotene Group
Active Comparator
干预措施: Tamibarotene (Drug)
Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in TKV from baseline
时间窗: 52 Week after administration of Investigational Product
TKV
次要结局
- Changes in TLV from baseline(52 Week after administration of Investigational Product)
- Changes in eGFR from baseline(52 Week after administration of Investigational Product)
- Incidence of adverse events(1 year)
研究者
研究点 (8)
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