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Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease. In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.
We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in chronic kidney disease (CKD) patients. To test our hypothesis, we will first perform a randomized, Phase 1 clinical trial in a single center funded by an R01 NIDDK award. This is an interventional pharmacokinetic trial, with subjects randomized to different doses of Avmacol ES.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
University of Rochester Medical Center
Rochester, New York, United States
Start Date
May 2, 2022
Primary Completion Date
May 25, 2023
Completion Date
June 8, 2023
Last Updated
August 12, 2024
18
ACTUAL participants
Sulforaphane
DRUG
Lead Sponsor
University of Rochester
Collaborators
NCT06495385
NCT05138419
Data Source & Attribution
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