Chronic Kidney Disease Stage 3Phase 2NCT05797506
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
A Phase 2 study testing Sulforaphane (Avmacol Extra Strength) in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease Stage 4, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4
- What is being tested?
- Sulforaphane (Avmacol Extra Strength)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease - Randomized, Double-blind, Placebo-controlled Trial
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.
Read the detailed 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.
- Being tested
- Sulforaphane (Avmacol Extra Strength), Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphane (Avmacol Extra Strength)Drug
4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
PlaceboDietary supplement
These tablets will be matched placebos and will be provided by Avmacol.
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane (Avmacol Extra Strength) | Experimental | Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. Receives: Drug: Sulforaphane (Avmacol Extra Strength) |
| Placebo | Placebo comparator | Nutramax will provide the matched placebo tablets. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma 8 Isoprostane From Baseline
Plasma 8 isoprostane in picograms per milliliter was measured at baseline and at Months 1, 3, and 6. For each participant at each follow up visit, change from baseline was calculated as follow up value minus baseline value. Mean change and standard deviation are reported separately at Month 1, Month 3, and Month 6.
Measured: Baseline, Month 1, Month 3, and Month 6
Secondary outcomes (22)
Longitudinal Change in Urinary Albumin
Unit of measurement - μg/ml
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Protein/Creatinine Ratio
Unit of measurement - milligram per gram (mg/g)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Urine Nephrin
Unit of measurement - microgram per milliliter μg/mL
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Messenger RNA (mRNA) Levels of Cytoprotective Enzymes in Peripheral Blood Mononuclear Cells (PBMCs)
Unit of measurement - Relative copy number
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Messenger RNA (mRNA) Levels of Heat Shock Proteins in Peripheral Blood Mononuclear Cells (PBMCs)
Unit of measurement - Relative copy number
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Sodium as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Potassium as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Chloride as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Carbon Dioxide as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Anion Gap as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - milliequivalents per liter (mEq/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Blood Urea Nitrogen as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Creatinine as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Estimated Glomerular Filtration Rate (eGFR) as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - milliliters of cleansed blood per minute per body surface (mL/min/1.73m2)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Calcium as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Total Protein as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Grams Per Deciliter (g/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Albumin as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Grams Per Deciliter (g/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Total Bilirubin as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Aspartate Transaminase (AST) as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - units per liter (U/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Alanine Transaminase (ALT) as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - units per liter (U/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Alkaline Phosphatase (ALP) as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - units per liter (U/L)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Phosphorus as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Glucose as Part of Comprehensive Metabolic Panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Measured: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start3 May 2023
- Primary completion25 Apr 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease Stage 3Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, Nutramax Laboratories, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Thu Le, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797506
- Sponsor's protocol ID
- STUDY00008014
- Other IDs
- R01DK128677
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease - Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05797506
- Acronym / sponsor ID
- STUDY00008014
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- University of Virginia, Nutramax Laboratories, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Posted 18 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane (Avmacol Extra Strength) | Experimental | Drug: Sulforaphane (Avmacol Extra Strength)Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNutramax will provide the matched placebo tablets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphane (Avmacol Extra Strength)4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4. | Drug | Sulforaphane (Avmacol Extra Strength) |
| PlaceboThese tablets will be matched placebos and will be provided by Avmacol. | Dietary supplement | Placebo |
Primary outcome
Change in Plasma 8 Isoprostane From Baseline
Time frame: Baseline, Month 1, Month 3, and Month 6
Plasma 8 isoprostane in picograms per milliliter was measured at baseline and at Months 1, 3, and 6. For each participant at each follow up visit, change from baseline was calculated as follow up value minus baseline value. Mean change and standard deviation are reported separately at Month 1, Month 3, and Month 6.
22 secondary outcomes
Longitudinal Change in Urinary Albumin
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Protein/Creatinine Ratio
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Urine Nephrin
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Messenger RNA (mRNA) Levels of Cytoprotective Enzymes in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Messenger RNA (mRNA) Levels of Heat Shock Proteins in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Sodium as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Potassium as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Chloride as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Carbon Dioxide as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Anion Gap as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Blood Urea Nitrogen as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Creatinine as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Estimated Glomerular Filtration Rate (eGFR) as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Calcium as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Total Protein as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Albumin as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Total Bilirubin as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Aspartate Transaminase (AST) as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Alanine Transaminase (ALT) as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Alkaline Phosphatase (ALP) as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Phosphorus as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal Change in Glucose as Part of Comprehensive Metabolic Panel (CMP)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulforaphane (Avmacol Extra Strength) in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease Stage 4, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma 8 Isoprostane From Baseline (time frame: Baseline, Month 1, Month 3, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.