NCT05153174

Study of Sulphoraphane in Chronic Kidney Disease

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease. In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.

Detailed description

We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in chronic kidney disease (CKD) patients. To test our hypothesis, we will first perform a randomized, Phase 1 clinical trial in a single center funded by an R01 NIDDK award. This is an interventional pharmacokinetic trial, with subjects randomized to different doses of Avmacol ES.

Conditions

• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4

Interventions

Type	Name	Description
DRUG	Sulforaphane	This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-05-25
• Completion: 2023-06-08
• First posted: 2021-12-10
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study