Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
Sponsored by University of Rochester
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Age ≥ 18 years and ≤ 80 years
- Estimated glomerular filtration rate (eGFR) ≥ 20 and < 60 mL/min/1.73m2 and a decline in eGFR of ≥ 3 ml/min/1.73m2 /year in the previous 12 ± 2 months
- Able to provide consent
- Able to swallow Avmacol ES or placebo capsules
Exclusion Criteria
- Significant co-morbid conditions with life expectancy of < 1 year
- Serum potassium of > 5.5 milliequivalents per liter (mEq/L) at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, known Ejection Fraction (EF) ≤ 30% or hospital admission for heart failure within the past 3 months
- Factors judged to limit adherence to interventions based on appointment attendance and medication treatment compliance; PI will make this determination
- Current participation in another medical intervention study
- Known to be pregnant or planning to become pregnant or currently breastfeeding; determined by self-report and medical record history. A urine pregnancy test will be completed for individuals of childbearing potential before administering the study drug, and repeated thereafter at every study visit (~ every 3-4 months)
- History of dementia documented in the medical record
- On anticoagulants or immunosuppression
- Under treatment for cancer
- Delayed gastric emptying or similar GI conditions Non-English-speaking individuals are excluded in this randomized phase of the study because the lack of English proficiency will affect a subject's ability to report problems or adverse events. If a patient cannot read, the consent form will be read to them by the research coordinator.