~4 spots leftby May 2025

Sulforaphane for Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: University of Rochester
Prior Safety Data

Trial Summary

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.

Research Team

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 am between 18 and 80 years old.
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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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Treatment Details

Interventions

  • Sulforaphane (Avmacol Extra Strength) (Phytochemical)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sulforaphane (Avmacol Extra Strength)Experimental Treatment1 Intervention
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
Group II: PlaceboPlacebo Group1 Intervention
Nutramax will provide the matched placebo tablets.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+
Kevin Koch profile image

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker profile image

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

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+
Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+
James E. Ryan profile image

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings profile image

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia