Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.

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

Details

• Lead Sponsor: University of Rochester
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Nutramax Laboratories, Inc.; University of Virginia
• Treatments: Sulforaphane

Criteria

Inclusion Criteria:

• Age ≥ 18 years and ≤ 80 years

• Estimated glomerular filtration rate (eGFR) ≥ 20 and < 60 mL/min/1.73m2 and a decline in eGFR of ≥ 3 ml/min/1.73m2 /year in the previous 12 ± 2 months

• Average blood pressure (BP) recorded in electronic medical record (EMR), or patient's own home recording of < 140/90 mm Hg within the 6 months prior to initiation of Avmacol Extra Strength (ES) or placebo, or achieved BP of < 140/90 mm Hg at the next clinic visit after adjustment of medications by their nephrology provider (see below).

• Able to provide consent

• Able to swallow Avmacol ES or placebo capsules

Exclusion Criteria:

• Significant co-morbid conditions with life expectancy of < 1 year

• Uncontrolled hypertension; an average recorded blood pressure ≥140/90 mmHg over the past 6 months

• Serum potassium of > 5.5 milliequivalents per liter (mEq/L) at screening

• New York Heart Association Class 3 or 4 heart failure symptoms, known Ejection Fraction (EF) ≤ 30% or hospital admission for heart failure within the past 3 months

• Factors judged to limit adherence to interventions based on appointment attendance and medication treatment compliance; PI will make this determination

• Current participation in another medical intervention study

• Known to be pregnant or planning to become pregnant or currently breastfeeding; determined by self-report and medical record history. A urine pregnancy test will be completed for individuals of childbearing potential before administering the study drug, and repeated thereafter at every study visit (~ every 3-4 months)

• History of dementia documented in the medical record

• On anticoagulants or immunosuppression

• Under treatment for cancer

• Delayed gastric emptying or similar GI conditions