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

NCT05797506 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY00008014R01DK128677
• Study Type: interventional
• Target: 96
• 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 (1)

• 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 Outcomes (22)

• Longitudinal Change in Urinary Albumin

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

• Longitudinal Change in Protein/Creatinine Ratio

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

• Longitudinal Change in Urine Nephrin

  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)

  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)

  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

Results Point of Contact

• Title: Thu H. Le, MD, FAHA
• Organization: University of California, Irvine

thuhl@hs.uci.edu

714-456-3224

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)