Sulforaphane for Chronic Kidney Disease

Overseen By Sharvari Sonawane, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Heart failure, Cancer, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulants (blood thinners) or immunosuppression (medications that lower the immune system).

What data supports the effectiveness of the treatment Sulforaphane (Avmacol Extra Strength) for Chronic Kidney Disease?

Research suggests that sulforaphane, found in certain vegetables, may help protect kidneys by reducing inflammation and oxidative stress (damage caused by free radicals) in preclinical models of kidney diseases. However, specific data on its effectiveness in chronic kidney disease patients is limited. ^{1 2 3 4 5}

Is sulforaphane safe for humans?

Sulforaphane, found in vegetables like broccoli, is generally considered safe as it is a common part of the diet. However, some studies suggest caution with high doses, especially for kidney cells, as it may affect cell behavior. ^{1 4 5 6 7}

How is the treatment sulforaphane unique for chronic kidney disease?

Sulforaphane is unique for chronic kidney disease because it is a natural compound found in cruciferous vegetables that activates the Nrf2 pathway, which helps protect cells from oxidative stress and inflammation. This approach is different from standard treatments as it uses a dietary component to potentially improve kidney health. ^{1 3 4 5 8}

What is the purpose of this 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.

Eligibility Criteria

Adults aged 18-80 with moderate chronic kidney disease, specifically those whose kidneys are filtering at a reduced rate and have shown decline in the past year. Participants must be able to swallow pills and give consent. Excluded are pregnant or breastfeeding individuals, those on anticoagulants or immunosuppressants, cancer patients, non-English speakers, and anyone with severe health issues affecting survival beyond a year.

Inclusion Criteria

My kidney function is low but not extremely poor, and it has been getting worse over the last year.

Able to provide consent

I can swallow pills without difficulty.

Exclusion Criteria

I am currently receiving treatment for cancer.

I am currently taking blood thinners or medications that affect my immune system.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacokinetic (PK) Phase

Establishing a safe dose of 4 tablets once daily in participants with CKD Stages 3 - 4

4 weeks

Treatment

Participants receive either Avmacol ES or placebo in a randomized, double-blind manner

6 months

4 visits (in-person) at baseline, month 1, month 3, and month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sulforaphane (Avmacol Extra Strength)

Trial Overview The trial is testing Avmacol Extra Strength's ability to slow down kidney disease progression by comparing it against a placebo. It's double-blind (neither doctors nor participants know who gets what), randomized (participants randomly assigned to groups), and aims to see if this supplement can reduce oxidative stress and inflammation in CKD patients.

Participant Groups

Group I: Sulforaphane (Avmacol Extra Strength) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Nutramax will provide the matched placebo tablets.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Nutramax Laboratories, Inc.

Industry Sponsor

Trials

2

Recruited

110+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Findings from Research

Supplementation with vegetable sources of alpha-linolenic acid (ALA) significantly reduced the inflammatory marker C-reactive protein (CRP) in patients with chronic kidney disease (CKD), indicating its potential anti-inflammatory benefits.

However, ALA supplementation did not show any significant effects on lipid profiles, including total cholesterol, HDL, LDL, or triglycerides, suggesting that while it may help with inflammation, it does not improve lipid levels in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supplementation with vegetable sources of alpha-linolenic acid (ALA) on inflammatory markers and lipid profile in individuals with chronic kidney disease: A systematic review and meta-analysis. de Abreu, AM., Copetti, CLK., Hauschild, DB., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane decreases kidney injury after transplantation in rats: role of mitochondrial damage. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Effects of supplementation with vegetable sources of alpha-linolenic acid (ALA) on inflammatory markers and lipid profile in individuals with chronic kidney disease: A systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane Supplementation Did Not Modulate NRF2 and NF-kB mRNA Expressions in Hemodialysis Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cruciferous vegetables: rationale for exploring potential salutary effects of sulforaphane-rich foods in patients with chronic kidney disease. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sulforaphane exhibits potent renoprotective effects in preclinical models of kidney diseases: A systematic review and meta-analysis. [2023]

6. Iran pubmed.ncbi.nlm.nih.gov

Sulforaphane, a Chemopreventive Compound Induces Necrotic Behavior and Inhibits S-phase of Cell Cycle in Human Kidney Cells in Vitro. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Sulforaphane prevents maleic acid-induced nephropathy by modulating renal hemodynamics, mitochondrial bioenergetics and oxidative stress. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The synthesis of sulforaphane analogues and their protection effect against cisplatin induced cytotoxicity in kidney cells. [2021]