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

Phase 2

Recruiting

• Conditions: Pediatric Kidney Disease
• Interventions: Drug: Sulforaphane

• Registration Number: NCT05653492
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2023-05-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Sulforaphane	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)
Group 2	Sulforaphane	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)
Group 3	Sulforaphane	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)

Primary Outcome Measures

Name	Time	Method
mean maximum concentration of drug in blood	8 hours
mean area under the curve of drug concentration in blood	8 hours
mean half life of drug in blood	8 hours

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States