Study of Sulphoraphane in Chronic Kidney Disease

University of Rochester

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease stage3; Chronic Kidney Disease stage4

Treatments: Drug: Sulforaphane

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05153174

STUDY00006759

1R01DK128677-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

2 tablets of Sulforaphane

Experimental group

Description:

Participants will be given 2 extra strength tablets per day

Treatment:

Drug: Sulforaphane

4 tablets of Sulforaphane

Experimental group

Description:

Participants will be given 4 extra strength tablets per day

Treatment:

Drug: Sulforaphane