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Completed

NCT Number: NCT05153174

Study of Sulphoraphane 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.

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Key information

Conditions

Chronic Kidney Disease stage3 Chronic Kidney Disease stage4

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulforaphane

Drug

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

Other names: Avmacol

Primary outcomes

  1. Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma

    Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose

    Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.

  2. Area Under the Concentration-Time Curve (AUC 0-8h) in Urine

    Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose

    Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.

  3. Number of Participants With an Adverse Event

    Time frame: day 7

    Adverse Event is any side effect outside of the subject's baseline.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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