Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Rochester
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- mean area under the curve of drug concentration in blood
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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)
Intervention: 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)
Intervention: 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)
Intervention: Sulforaphane (Drug)
Outcomes
Primary Outcomes
mean area under the curve of drug concentration in blood
Time Frame: 8 hours
mean half life of drug in blood
Time Frame: 8 hours
mean maximum concentration of drug in blood
Time Frame: 8 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Rebecca Levy
Assistant Professor
University of Rochester