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Phytochemical
Sulforaphane for Pediatric Kidney Disease
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
My kidney function is moderately to severely reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean area under the curve of drug concentration in blood
mean half life of drug in blood
mean maximum concentration of drug in blood
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
840 Previous Clinical Trials
534,238 Total Patients Enrolled
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,402 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over 25 being admitted to this investigation?
"Applicants who are between 1 and 17 years old, inclusively, meet the eligibility criteria for this medical trial."
Answered by AI
What potential harm could befall patients who are classified as Group 1?
"The safety of Group 1 was rated a 2, as it is currently undergoing Phase 2 trials. This means there are some data points that suggest it might be safe but none to verify efficacy."
Answered by AI
Am I qualified to participate in this scientific experiment?
"For those to be considered for this clinical trial, they must have a diagnosis of pediatric kidney disease and fall between the ages of 1 Year and 17. A maximum limit of 12 participants can enroll in the study."
Answered by AI
Is this trial presently accepting participants?
"This medical trial, which was initially made public on March 1st 2023 and last modified December 7th 2022 is not recruiting participants at this time. Fortunately, there are currently 489 distinct clinical studies that are actively enrolling patients."
Answered by AI
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