Breast Cancer Clinical Trial

Study of Sulphoraphane in Chronic Kidney Disease

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT05153174

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester Medical Center
Rochester New York, 14642, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT05153174

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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