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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4
• Intervention / Treatment: Drug: Sulforaphane (Avmacol Extra Strength); Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulforaphane (Avmacol Extra Strength); Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.	Drug: Sulforaphane (Avmacol Extra Strength); 4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
Placebo Comparator: Placebo; Nutramax will provide the matched placebo tablets.	Dietary supplement: Placebo; These tablets will be matched placebos and will be provided by Avmacol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 1, Month 3, and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Antineoplastic Agents; Physiological Effects of Drugs; Protective Agents; Anticarcinogenic Agents; sulforaphane
• Other Study ID Numbers: STUDY00008014; R01DK128677 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No