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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 belowSelect...
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:Select...
I am currently on blood thinners, immune system suppressors, or chemotherapy.
Select...
I have a heart condition affecting its structure.
Select...
I weigh less than 30 kg.
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I have been diagnosed with cancer or HIV.
Select...
I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
867 Previous Clinical Trials
548,870 Total Patients Enrolled
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,402 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on blood thinners, immune system suppressors, or chemotherapy.I have a heart condition affecting its structure.You are not expected to live for more than a year.I have been diagnosed with chronic kidney disease.My kidney function is moderately to severely reduced.I weigh less than 30 kg.I have been diagnosed with cancer or HIV.I have had a solid organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3
- Group 2: Group 1
- Group 3: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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