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Study of Sulphoraphane in Chronic Kidney Disease

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05153174
Collaborator
National Institutes of Health (NIH) (NIH)
24
Enrollment
1
Location
3
Arms
19
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
Actual Study Start Date :
May 2, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•
    Experimental: 6 tablets of Sulforaphane

    Participants will be given 6 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Concentration-Time Curve (AUC 0-8h) in serum [prior to initial dose on day 7 and 2, 4, and 8 hours post-dose]

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

    2. Area Under the Concentration-Time Curve (AUC 0-8h) in urine [prior to initial dose on day 7 and 2, 4, and 8 hours post-dose]

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

    3. Number of participants with an adverse event [day 7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester
    • National Institutes of Health (NIH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thu Le, Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT05153174
    Other Study ID Numbers:
    • STUDY00002021
    First Posted:
    Dec 10, 2021
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Sulforaphane

    Study Results

    No Results Posted as of May 19, 2022