Study of Sulphoraphane in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease stage4, Chronic Kidney Disease stage3

Intervention / Treatment
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* Drug: Sulforaphane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eGFR ≥ 20 and <60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period able to provide consent able to swallow capsules Exclusion Criteria: significant co-morbid conditions with life expectancy of <1 year uncontrolled hypertension serum potassium of >5.5 mEq/L at screening New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months factors judged to limit adherence to interventions current participation in another study pregnancy or planning to become pregnant or currently breastfeeding history of dementia on anticoagulants or immunosuppression under treatment for cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 tablets of Sulforaphane<br>Participants will be given 2 extra strength tablets per day | Drug: Sulforaphane<br>* This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.<br>* Other names: Avmacol;|
| Experimental: 4 tablets of Sulforaphane<br>Participants will be given 4 extra strength tablets per day | Drug: Sulforaphane<br>* This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.<br>* Other names: Avmacol;|
| Experimental: 6 tablets of Sulforaphane<br>Participants will be given 6 extra strength tablets per day | Drug: Sulforaphane<br>* This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.<br>* Other names: Avmacol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time Curve (AUC 0-8h) in serum | Sulforaphane drug levels will be measured in serum at 0, 2, 4, and 8 hours. | prior to initial dose on day 7 and 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, 2, 4, and 8 hours. | prior to initial dose on day 7 and 2, 4, and 8 hours post-dose | 
| Number of participants with an adverse event |  | day 7 |