Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
NCT ID: NCT05797506
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2023-05-03
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sulforaphane (Avmacol Extra Strength)
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
Sulforaphane (Avmacol Extra Strength)
4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
Placebo
Nutramax will provide the matched placebo tablets.
Placebo
These tablets will be matched placebos and will be provided by Avmacol.
Interventions
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Sulforaphane (Avmacol Extra Strength)
4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
Placebo
These tablets will be matched placebos and will be provided by Avmacol.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Nutramax Laboratories, Inc.
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Rochester
OTHER
Responsible Party
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Thu Le
John J. Kuiper Distinguished Professor of Medicine & Chief, Division of Nephrology
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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STUDY00008014
Identifier Type: -
Identifier Source: org_study_id
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