Study of Sulphoraphane in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sulforaphane
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease stage3
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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
2 tablets of Sulforaphane
4 tablets of Sulforaphane
6 tablets of Sulforaphane
Arm Description
Participants will be given 2 extra strength tablets per day
Participants will be given 4 extra strength tablets per day
Participants will be given 6 extra strength tablets per day
Outcomes
Primary Outcome Measures
Area Under the Concentration-Time Curve (AUC 0-8h) in serum
Sulforaphane drug levels will be measured in serum at 0, 2, 4, and 8 hours.
Area Under the Concentration-Time Curve (AUC 0-8h) in urine
Sulforaphane drug levels will be measured in urine at 0, 2, 4, and 8 hours.
Number of participants with an adverse event
Secondary Outcome Measures
Full Information
NCT ID
NCT05153174
First Posted
November 29, 2021
Last Updated
July 13, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05153174
Brief Title
Study of Sulphoraphane in Chronic Kidney Disease
Official Title
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 tablets of Sulforaphane
Arm Type
Experimental
Arm Description
Participants will be given 2 extra strength tablets per day
Arm Title
4 tablets of Sulforaphane
Arm Type
Experimental
Arm Description
Participants will be given 4 extra strength tablets per day
Arm Title
6 tablets of Sulforaphane
Arm Type
Experimental
Arm Description
Participants will be given 6 extra strength tablets per day
Intervention Type
Drug
Intervention Name(s)
Sulforaphane
Other Intervention Name(s)
Avmacol
Intervention Description
This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.
Primary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve (AUC 0-8h) in serum
Description
Sulforaphane drug levels will be measured in serum at 0, 2, 4, and 8 hours.
Time Frame
prior to initial dose on day 7 and 2, 4, and 8 hours post-dose
Title
Area Under the Concentration-Time Curve (AUC 0-8h) in urine
Description
Sulforaphane drug levels will be measured in urine at 0, 2, 4, and 8 hours.
Time Frame
prior to initial dose on day 7 and 2, 4, and 8 hours post-dose
Title
Number of participants with an adverse event
Time Frame
day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared after publication
Learn more about this trial
Study of Sulphoraphane in Chronic Kidney Disease
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