Study of Sulphoraphane in Chronic Kidney Disease

NCT ID: NCT05153174

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2023-06-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 tablets of Sulforaphane

Participants will be given 2 extra strength tablets per day

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: DRUG

This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

4 tablets of Sulforaphane

Participants will be given 4 extra strength tablets per day

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: DRUG

This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Interventions

Sulforaphane

This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Intervention Type: DRUG

Other Intervention Names

Avmacol

Eligibility Criteria

Inclusion Criteria

• eGFR ≥ 20 and <60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
• Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane
• stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
• able to provide consent
• able to swallow capsules

Exclusion Criteria

• significant co-morbid conditions with life expectancy of <1 year
• uncontrolled hypertension
• serum potassium of >5.5 mEq/L at screening
• New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
• factors judged to limit adherence to interventions
• current participation in another study
• pregnancy or planning to become pregnant or currently breastfeeding
• history of dementia
• on anticoagulants or immunosuppression
• under treatment for cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Thu Le

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thu H Le, MD, FAHA

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology Chief

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK128677-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006759

Identifier Type: -

Identifier Source: org_study_id