Sulforaphane for Pediatric Kidney Disease

Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Rochester

No Placebo Group

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children with moderate to advanced chronic kidney disease (CKD), specifically those with an eGFR of 20-59 mL/min/1.73m2. Parents must consent for participation. It's not suitable for kids under 30 kg, or those with cancer, HIV, organ transplants, heart issues, pregnancy plans, short life expectancy or on certain medications like anticoagulants.

Inclusion Criteria

I have been diagnosed with chronic kidney disease.

My kidney function is moderately to severely reduced.

Exclusion Criteria

I am currently on blood thinners, immune system suppressors, or chemotherapy.

I have a heart condition affecting its structure.

I weigh less than 30 kg.

I have been diagnosed with cancer or HIV.

I have had a solid organ transplant.

Treatment Details

The study tests the safety and tolerability of a supplement called Sulforaphane in children with CKD. The goal is to find out the right dose and see how it affects oxidative stress and inflammation markers in these patients.

3Treatment groups

Active Control

Group I: Group 3Active Control1 Intervention

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)

Group II: Group 1Active Control1 Intervention

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 III: Group 2Active Control1 Intervention

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)

Sulforaphane is already approved in United States for the following indications:

🇺🇸 Approved in United States as Avmacol ES for:

None approved; used in clinical trials for various conditions including chronic kidney disease and prevention of age-associated cardiac and vascular dysfunction