Sulforaphane for Chronic Kidney Disease

TL
SS
Overseen BySharvari Sonawane, MS
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sulforaphane, a compound found in broccoli, can slow the progression of Chronic Kidney Disease (CKD) and reduce inflammation and oxidative stress, harmful processes in the body. Participants will take either a sulforaphane supplement or a placebo (a pill with no active ingredient) to compare effects. This trial may suit those with CKD who have noticed declining kidney function over the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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).

Is there any evidence suggesting that Sulforaphane (Avmacol Extra Strength) is likely to be safe for humans?

Research has shown that sulforaphane, an ingredient in Avmacol Extra Strength, is safe for use. In studies involving individuals with Chronic Kidney Disease (CKD), taking four tablets daily was well-tolerated, with no serious side effects reported. Some research indicates that sulforaphane reaches its peak level in the blood of CKD patients more slowly than in those without CKD, but this does not appear to impact its safety.

Overall, evidence suggests that Avmacol Extra Strength is safe, with no major negative effects reported.12345

Why do researchers think this study treatment might be promising for chronic kidney disease?

Researchers are excited about sulforaphane (Avmacol Extra Strength) for chronic kidney disease because it offers a fresh approach with its active ingredient derived from broccoli sprouts. Unlike the standard treatments, which often focus on controlling blood pressure and blood sugar, sulforaphane works by potentially reducing inflammation and oxidative stress in the kidneys. This unique mechanism could provide a new avenue for protecting kidney function, which is why it's generating interest in the medical community.

What evidence suggests that Sulforaphane might be an effective treatment for Chronic Kidney Disease?

Research has shown that sulforaphane, an ingredient in Avmacol Extra Strength, might help slow chronic kidney disease (CKD). Studies have found that it can reduce signs of cell damage and inflammation, which are often elevated in people with CKD. This trial will test sulforaphane as a treatment option, with participants taking four tablets of Avmacol Extra Strength daily. This suggests that sulforaphane could help manage CKD by protecting the kidneys from further harm. While these findings are promising, additional trials are needed to confirm its benefits for CKD patients.12346

Are You a Good Fit for This Trial?

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)
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sulforaphane (Avmacol Extra Strength)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ...The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and ...
Health Effects (Renal) Of Extra Strength Avmacol ...We hypothesize that daily intake of SFN - in the form of Avmacol Extra Strength (ES) - will decrease CKD progression rate and decrease markers of oxidative ...
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ...We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative ...
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ...Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease. Non Recruiting.
Trial | NCT05797506The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and ...
Health Effects (Renal) of Extra Strength Avmacol (HEROES)...We are testing this hypothesis using Avmacol Extra Strength (ES) in a Phase 2 randomized double-blind placebo-controlled safety and feasibility trial.
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