Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease

Phase 2Active Not RecruitingNCT05653492

University of Rochester12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Kidney Disease

Interventions

SulforaphaneDRUG

Dosing study one to four 30 mg/d tablets depending on weight

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

mean half life of drug in blood

Time frame: 8 hours

mean maximum concentration of drug in blood

Time frame: 8 hours

mean area under the curve of drug concentration in blood

Time frame: 8 hours

Data from ClinicalTrials.gov

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