Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
NCT05797506 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-05-18
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
Interventions
- DRUG
-
Sulforaphane (Avmacol Extra Strength)
4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
- DIETARY_SUPPLEMENT
-
Placebo
These tablets will be matched placebos and will be provided by Avmacol.
Sponsors & Collaborators
-
University of Virginia
collaborator OTHER -
Nutramax Laboratories, Inc.
collaborator INDUSTRY -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
University of Rochester
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-03
- Primary Completion
- 2025-04-25
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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