Pediatric Kidney Disease
Conditions
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.
Interventions
DRUGSulforaphane
Dosing study one to four 30 mg/d tablets depending on weight
Sponsors
Renal Research Institute
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean half life of drug in blood | 8 hours |
| mean maximum concentration of drug in blood | 8 hours |
| mean area under the curve of drug concentration in blood | 8 hours |
Countries
United States
Outcome results
None listed