Clinical trial NCT05153174: Study of Sulphoraphane in Chronic Kidney Disease
Official title: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
timeFrame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
measure: Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
timeFrame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
measure: Number of Participants With an Adverse Event
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Division of Nephrology Chief
name: Thu H Le, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
References: