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Antioxidant
Study of Sulphoraphane in Chronic Kidney Disease
Phase 1
Waitlist Available
Led By Thu H Le, MD, FAHA
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing sulforaphane, a compound that helps protect cells from damage, in patients with chronic kidney disease. The goal is to find a safe dose for these patients. Sulforaphane works by boosting the body's natural defenses against harmful molecules. It has been studied for its protective effects against various types of kidney damage, including those caused by certain medications and toxins.
Eligible Conditions
- Chronic Kidney Disease
- Renal Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
Number of Participants With an Adverse Event
Side effects data
From 2023 Phase 2 trial • 43 Patients • NCT0323213881%
Others
62%
Flatulence
48%
Diarrhea
43%
Insomnia
38%
Stomachache
33%
Mood Alteration
33%
Constipation
29%
Dry Mouth
29%
Nausea
29%
Dizziness
24%
Tremor
19%
Belching
14%
Distension
14%
Headache
10%
Vomiting
5%
Bad taste
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sulforaphane (Study Drug)
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 4 tablets of SulforaphaneExperimental Treatment1 Intervention
Participants will be given 4 extra strength tablets per day
Group II: 2 tablets of SulforaphaneExperimental Treatment1 Intervention
Participants will be given 2 extra strength tablets per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulforaphane
2016
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,435 Total Patients Enrolled
University of RochesterLead Sponsor
872 Previous Clinical Trials
550,073 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,105 Total Patients Enrolled
Thu H Le, MD, FAHAPrincipal InvestigatorDivision of Nephrology Chief