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Phytochemical

Sulforaphane for Pediatric Kidney Disease

Phase 2
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of chronic kidney disease
eGFR 20-59 mL/min/1.73m2 at the time of enrollment
Must not have
Currently taking anticoagulants, immunosuppression, or chemotherapeutics
Structural heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will research if supplementing with sulforaphane can help children with kidney disease and study how it affects inflammation and oxidation in their bodies.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, Sulforaphane may cause gastrointestinal discomforts such as gas or bloating and possible skin reactions; however, this study aims to determine its overall safety profile in the pediatric CKD population.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic kidney disease.
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My kidney function is moderately to severely reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on blood thinners, immune system suppressors, or chemotherapy.
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I have a heart condition affecting its structure.
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I weigh less than 30 kg.
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I have been diagnosed with cancer or HIV.
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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
550,085 Total Patients Enrolled
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,402 Total Patients Enrolled

Media Library

Sulforaphane (Phytochemical) Clinical Trial Eligibility Overview. Trial Name: NCT05653492 — Phase 2
Pediatric Nephropathy Research Study Groups: Group 3, Group 1, Group 2
Pediatric Nephropathy Clinical Trial 2023: Sulforaphane Highlights & Side Effects. Trial Name: NCT05653492 — Phase 2
Sulforaphane (Phytochemical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653492 — Phase 2
~2 spots leftby Apr 2025
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