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

NCT05797506 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00008014R01DK128677
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4

Outcome Measures

Primary Outcomes (30)

• Longitudinal change in the scores

  Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health questionnaire. Scoring: The questionnaire has two scores: Physical Health (physical health, physical function, pain, and fatigue items) and Mental Health (quality of life, mental health, satisfaction with discretionary social activities, and emotional problem items). In all cases, a high score means more of domain. T scores for both Physical and Mental Health scales. In all cases, a high score means more of domain. For example, higher scores on physical functioning measure indicate better health.

  Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

• Longitudinal change in the scores

  Modified Kansas City Cardiomyopathy questionnaire (KCCQ) - All KCCQ scores are scaled from 0 to 100. A higher score indicates better health status.

  Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

• Longitudinal change in the scores

  Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.0 - Gastrointestinal Belly Pain 5a questionnaire. The PROMIS GI measures use a T-score centered on the U.S. General Population. This means that a score of 50 represents the average of the general population (and that 10 represents the standard deviation). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like belly pain, a T-score of 60 is one SD worse than average. By comparison, a gastrointestinal symptom T-score of 40 is one SD better than average.

  Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

• Longitudinal change in both systolic and diastolic blood pressure

  Unit of measurement - millimeters of mercury (mmHg)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

• Longitudinal change in 8-isoprostane in plasma

  Unit of measurement - picograms per milliliter (pg/mL)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

• Longitudinal change in 8-isoprostane in urine

  Unit of measurement - picograms per milliliter (pg/mL)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

• Longitudinal change in urinary albumin

  Unit of measurement - μg/ml

  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)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

• Longitudinal change in plasma hydrogen sulfide

  Unit of measurement - Nanomolar (nM)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

• Longitudinal change in plasma interleukin-6

  Unit of measurement - picograms per milliliter (pg/mL)

  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

  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

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  Four timepoints per patient (baseline, month 1, month 3, and month 6)

Study Arms (2)

Sulforaphane (Avmacol Extra Strength)

EXPERIMENTAL

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

Drug: Sulforaphane (Avmacol Extra Strength)

Placebo

PLACEBO COMPARATOR

Nutramax will provide the matched placebo tablets.

Dietary Supplement: Placebo

Interventions

Sulforaphane (Avmacol Extra Strength) DRUG

4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.

Sulforaphane (Avmacol Extra Strength)

Placebo DIETARY_SUPPLEMENT

These tablets will be matched placebos and will be provided by Avmacol.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• University of Virginia: collaborator
• Nutramax Laboratories, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John J. Kuiper Distinguished Professor of Medicine & Chief, Division of Nephrology

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 4, 2023
• Study Start: May 3, 2023
• Primary Completion: April 25, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)