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Study of Sulphoraphane in Chronic Kidney Disease | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT05153174

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 exper...

Lead sponsor: University of Rochester•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Rochester

Collaborators

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

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.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 12, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment18

Start dateMay 2022

Last updatedAug 12, 2024

Condition

Chronic Kidney Disease stage3 Chronic Kidney Disease stage4

Locations shown

University of Rochester Medical Center

Rochester, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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