Clinical trial NCT05797506: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
Official title: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease - Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease Stage 3
Chronic Kidney Disease Stage 4
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Nutramax Laboratories, Inc.
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-04
Enrollment: 100
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 Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.

Detailed description: The investigators will test the safety and efficacy of Avmacol ES in Chronic Kidney Disease (CKD) patients. After having established a safe dose of 4 tablets once daily in participants with CKD Stages 3 - 4 in the pharmacokinetic (PK) phase, the investigators will enroll 100 participants from the Kidney Clinic at the University of Rochester Medical Center and Highland Hospital with CKD stages 3 - 4 who will be randomized to Avmacol ES or placebo in a 1:1 ratio in a blinded manner.

Eligibility criteria: 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.

Primary outcomes:
measure: Longitudinal change in the scores
timeFrame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
measure: Longitudinal change in the scores
timeFrame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
measure: Longitudinal change in the scores
timeFrame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
measure: Longitudinal change in both systolic and diastolic blood pressure
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in 8-isoprostane in plasma
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in 8-isoprostane in urine
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in urinary albumin
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in protein/creatinine ratio
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in plasma hydrogen sulfide
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in plasma interleukin-6
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in urine nephrin
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in messenger RNA (mRNA) levels of cytoprotective enzymes in peripheral blood mononuclear cells (PBMCs)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in messenger RNA (mRNA) levels of heat shock proteins in peripheral blood mononuclear cells (PBMCs)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in sodium as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in potassium as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in chloride as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in carbon Dioxide as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in anion Gap as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in blood urea nitrogen as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in creatinine as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in estimated Glomerular Filtration Rate (eGFR) as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in calcium as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in total protein as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in albumin as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in total bilirubin as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in aspartate transaminase (AST) as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in alanine transaminase (ALT) as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in alkaline phosphatase (ALP) as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in phosphorus as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
measure: Longitudinal change in glucose as part of comprehensive metabolic panel (CMP)
timeFrame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: