NCT03423810已完成早期 1 期
Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in polycystin-1 (PC1)
研究概览
简要总结
The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ADPKD
- •estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m^2
排除标准
- •History of systemic lupus erythematous or other rheumatologic disorder
- •Baseline anti-nuclear antibody (ANA) >1:80 for females and >1:40 for males
- •Blood pressure < 120/80 without anti-hypertensive
- •Angina pectoris or myocardial infarction in the last 6 months
- •Liver disease
- •Allergy to hydralazine
研究组 & 干预措施
Group 1: Hydralazine
Experimental
Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.
干预措施: Hydralazine (Drug)
结局指标
主要结局
Change in polycystin-1 (PC1)
时间窗: Change from Baseline to Week 8
Change in mucin-like protocadherin (MUPCDH)
时间窗: Change from Baseline to Week 8
次要结局
- Circulating methylated RASAL1 levels(Change from Baseline to Week 8)
研究者
研究点 (1)
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