Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With an Adverse Event
研究概览
简要总结
The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease.
In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.
详细描述
We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in chronic kidney disease (CKD) patients. To test our hypothesis, we will first perform a randomized, Phase 1 clinical trial in a single center funded by an R01 NIDDK award. This is an interventional pharmacokinetic trial, with subjects randomized to different doses of Avmacol ES.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eGFR ≥ 20 and <60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
- •Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane
- •stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
- •able to provide consent
- •able to swallow capsules
排除标准
- •significant co-morbid conditions with life expectancy of <1 year
- •uncontrolled hypertension
- •serum potassium of >5.5 mEq/L at screening
- •New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
- •factors judged to limit adherence to interventions
- •current participation in another study
- •pregnancy or planning to become pregnant or currently breastfeeding
- •history of dementia
- •on anticoagulants or immunosuppression
- •under treatment for cancer
研究组 & 干预措施
2 tablets of Sulforaphane
Participants will be given 2 extra strength tablets per day
干预措施: Sulforaphane (Drug)
4 tablets of Sulforaphane
Participants will be given 4 extra strength tablets per day
干预措施: Sulforaphane (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event
时间窗: day 7
Adverse Event is any side effect outside of the subject's baseline.
Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
时间窗: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
时间窗: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.
次要结局
未报告次要终点
研究者
Thu Le
Professor
University of Rochester