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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.
University of Rochester Medical Center
Rochester, New York, United States
Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.
Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.
Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Number of Participants With an Adverse Event
Adverse Event is any side effect outside of the subject's baseline.
Time frame: day 7
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