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Completed

NCT Number: NCT05797506

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sulforaphane (Avmacol Extra Strength)

Drug

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Longitudinal Change in Urinary Albumin

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

    Unit of measurement - μg/ml

  2. Longitudinal Change in Protein/Creatinine Ratio

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

    Unit of measurement - milligram per gram (mg/g)

  3. Longitudinal Change in Urine Nephrin

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

    Unit of measurement - microgram per milliliter μg/mL

  4. 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)

    Unit of measurement - Relative copy number

  5. 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)

    Unit of measurement - Relative copy number

  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)

    Unit of measurement - Millimoles per liter (mmol/L)

  7. 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)

    Unit of measurement - Millimoles per liter (mmol/L)

  8. 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)

    Unit of measurement - Millimoles per liter (mmol/L)

  9. 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)

    Unit of measurement - Millimoles per liter (mmol/L)

  10. 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)

    Unit of measurement - milliequivalents per liter (mEq/L)

  11. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

  12. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

  13. 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)

    Unit of measurement - milliliters of cleansed blood per minute per body surface (mL/min/1.73m2)

  14. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

  15. 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)

    Unit of measurement - Grams Per Deciliter (g/dL)

  16. 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)

    Unit of measurement - Grams Per Deciliter (g/dL)

  17. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

  18. 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)

    Unit of measurement - units per liter (U/L)

  19. 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)

    Unit of measurement - units per liter (U/L)

  20. 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)

    Unit of measurement - units per liter (U/L)

  21. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

  22. 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)

    Unit of measurement - Milligrams per decilitre (mg/dL)

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

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

Registry information

Official study title

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease - Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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