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Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD


Description

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.

Trial 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

Study Info

Organization

University of Rochester


Primary Outcome

mean half life of drug in blood


Outcome Timeframe 8 hours

NCTID NCT05653492

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-05-15

Completion Date 2024-08-31

Enrollment Target 12

Interventions

DRUG Sulforaphane

Locations Recruiting

University of Rochester Medical Center

United States, New York, Rochester


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