Study of Sulphoraphane in Chronic Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease stage3
• Intervention / Treatment: Drug: Sulforaphane

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 tablets of Sulforaphane; Participants will be given 2 extra strength tablets per day	Drug: Sulforaphane; This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.; Other Names: Avmacol
Experimental: 4 tablets of Sulforaphane; Participants will be given 4 extra strength tablets per day	Drug: Sulforaphane; This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.; Other Names: Avmacol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma	Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.	prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine	Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.	prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Number of Participants With an Adverse Event	Adverse Event is any side effect outside of the subject's baseline.	day 7

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Thu H Le, MD, FAHA, Division of Nephrology Chief

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: STUDY00006759; 1R01DK128677-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared after publication
• IPD Sharing Time Frame: May 2024 data is available. End date to be determined.
• IPD Sharing Access Criteria: clinicaltrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No