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

University of Rochester

Status and phase: Active, not recruiting; Phase 2

Conditions: Pediatric Kidney Disease

Treatments: Drug: Sulforaphane

Study type: Interventional

Funder types: Other

Identifiers

NCT05653492

STUDY00007450

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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)

Treatment:

Drug: Sulforaphane

Group 2

Active Comparator group

Description:

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)

Treatment:

Drug: Sulforaphane

Group 3

Active Comparator group

Description:

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)

Treatment:

Drug: Sulforaphane