Pediatric Kidney Disease Clinical Trial
Official title:
Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD
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.
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | August 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Rochester Medical Center | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rochester | Renal Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mean half life of drug in blood | 8 hours | ||
| Primary | mean maximum concentration of drug in blood | 8 hours | ||
| Primary | mean area under the curve of drug concentration in blood | 8 hours |
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