Study of Sulphoraphane in Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Institutes of Health (NIH)
• Treatments: Sulforaphane

Criteria

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