Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- mean area under the curve of drug concentration in blood
研究概览
简要总结
This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of chronic of kidney disease
- •have eGFR 20-59 mL/min/1.73m2 at the time of enrollment
- •parents must be able to provide consent
排除标准
- •weight <30 kg
- •cancer or HIV diagnosis
- •history of solid organ transplantation (including kidney transplant)
- •structural heart disease
- •currently pregnant or plan to become pregnant
- •life expectancy is less than one year
- •Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics
研究组 & 干预措施
Group 1
30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (60mg/d) 70-90 lbs; 3 tablets (90mg/d) >90 lbs; 4 tablets (120 mg/d)
干预措施: Sulforaphane (Drug)
Group 2
30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (60mg/d) >90 lbs; 2 tablets (60 mg/d)
干预措施: Sulforaphane (Drug)
Group 3
30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 1 tablet (30mg/d) >90 lbs; 1 tablet (30 mg/d)
干预措施: Sulforaphane (Drug)
结局指标
主要结局
mean area under the curve of drug concentration in blood
时间窗: 8 hours
mean half life of drug in blood
时间窗: 8 hours
mean maximum concentration of drug in blood
时间窗: 8 hours
次要结局
未报告次要终点
研究者
Rebecca Levy
Assistant Professor
University of Rochester