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

University of Rochester

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4

Treatments: Dietary Supplement: Placebo; Drug: Sulforaphane (Avmacol Extra Strength)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05797506

R01DK128677 (U.S. NIH Grant/Contract)

STUDY00008014

Details and patient eligibility

About

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.

Full description

The investigators will test the safety and efficacy of Avmacol ES in Chronic Kidney Disease (CKD) patients. After having established a safe dose of 4 tablets once daily in participants with CKD Stages 3 - 4 in the pharmacokinetic (PK) phase, the investigators will enroll 100 participants from the Kidney Clinic at the University of Rochester Medical Center and Highland Hospital with CKD stages 3 - 4 who will be randomized to Avmacol ES or placebo in a 1:1 ratio in a blinded manner.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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
• Able to provide consent
• Able to swallow Avmacol ES or placebo capsules

Exclusion criteria

• Significant co-morbid conditions with life expectancy of < 1 year
• 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 Non-English-speaking individuals are excluded in this randomized phase of the study because the lack of English proficiency will affect a subject's ability to report problems or adverse events. If a patient cannot read, the consent form will be read to them by the research coordinator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Sulforaphane (Avmacol Extra Strength)

Experimental group

Description:

Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.

Treatment:

Drug: Sulforaphane (Avmacol Extra Strength)

Placebo

Placebo Comparator group

Description:

Nutramax will provide the matched placebo tablets.

Treatment:

Dietary Supplement: Placebo