Phase 2
N=96
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
Chronic Kidney Disease Stage 3 · Chronic Kidney Disease Stage 4
Bottom Line
View on ClinicalTrials.gov: NCT05797506 ↗Enrolled (actual)
96
Serious AEs
1.0%
Results posted
May 2026
Primary outcome: Primary: Change in Plasma 8 Isoprostane From Baseline — 19.2; 35.0; 18.1; 56.3 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sulforaphane (Avmacol Extra Strength) (Drug); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma 8 Isoprostane From Baseline |
19.2; 35.0; 18.1; 56.3; 14.5; -1.7 | — |
| SECONDARY Longitudinal Change in Urinary Albumin |
— | — |
| SECONDARY Longitudinal Change in Protein/Creatinine Ratio |
— | — |
| SECONDARY Longitudinal Change in Urine Nephrin |
— | — |
| SECONDARY Longitudinal Change in Messenger RNA (mRNA) Levels of Cytoprotective Enzymes in Peripheral Blood Mononuclear Cells (PBMCs) |
— | — |
| SECONDARY Longitudinal Change in Messenger RNA (mRNA) Levels of Heat Shock Proteins in Peripheral Blood Mononuclear Cells (PBMCs) |
— | — |
| SECONDARY Longitudinal Change in Sodium as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Potassium as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Chloride as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Carbon Dioxide as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Anion Gap as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Blood Urea Nitrogen as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Creatinine as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Estimated Glomerular Filtration Rate (eGFR) as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Calcium as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Total Protein as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Albumin as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Total Bilirubin as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Aspartate Transaminase (AST) as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Alanine Transaminase (ALT) as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Alkaline Phosphatase (ALP) as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Phosphorus as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
| SECONDARY Longitudinal Change in Glucose as Part of Comprehensive Metabolic Panel (CMP) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years and ≤ 80 years
- Estimated glomerular filtration rate (eGFR) ≥ 20 and 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.
Data sourced from ClinicalTrials.gov (NCT05797506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.