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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
These tablets will be matched placebos and will be provided by Avmacol.
University of Rochester Medical Center
Rochester, New York, United States
Longitudinal change in the scores
Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health questionnaire. Scoring: The questionnaire has two scores: Physical Health (physical health, physical function, pain, and fatigue items) and Mental Health (quality of life, mental health, satisfaction with discretionary social activities, and emotional problem items). In all cases, a high score means more of domain. T scores for both Physical and Mental Health scales. In all cases, a high score means more of domain. For example, higher scores on physical functioning measure indicate better health.
Time frame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
Longitudinal change in the scores
Modified Kansas City Cardiomyopathy questionnaire (KCCQ) - All KCCQ scores are scaled from 0 to 100. A higher score indicates better health status.
Time frame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
Longitudinal change in the scores
Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.0 - Gastrointestinal Belly Pain 5a questionnaire. The PROMIS GI measures use a T-score centered on the U.S. General Population. This means that a score of 50 represents the average of the general population (and that 10 represents the standard deviation). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like belly pain, a T-score of 60 is one SD worse than average. By comparison, a gastrointestinal symptom T-score of 40 is one SD better than average.
Time frame: Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)
Longitudinal change in both systolic and diastolic blood pressure
Unit of measurement - millimeters of mercury (mmHg)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in 8-isoprostane in plasma
Unit of measurement - picograms per milliliter (pg/mL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in 8-isoprostane in urine
Unit of measurement - picograms per milliliter (pg/mL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in urinary albumin
Unit of measurement - μg/ml
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in protein/creatinine ratio
Unit of measurement - milligram per gram (mg/g)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in plasma hydrogen sulfide
Unit of measurement - Nanomolar (nM)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in plasma interleukin-6
Unit of measurement - picograms per milliliter (pg/mL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in urine nephrin
Unit of measurement - microgram per milliliter μg/mL
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in messenger RNA (mRNA) levels of cytoprotective enzymes in peripheral blood mononuclear cells (PBMCs)
Unit of measurement - Relative copy number
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in messenger RNA (mRNA) levels of heat shock proteins in peripheral blood mononuclear cells (PBMCs)
Unit of measurement - Relative copy number
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in sodium as part of comprehensive metabolic panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in potassium as part of comprehensive metabolic panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in chloride as part of comprehensive metabolic panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in carbon Dioxide as part of comprehensive metabolic panel (CMP)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in anion Gap as part of comprehensive metabolic panel (CMP)
Unit of measurement - milliequivalents per liter (mEq/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in blood urea nitrogen as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in creatinine as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in estimated Glomerular Filtration Rate (eGFR) as part of comprehensive metabolic panel (CMP)
Unit of measurement - milliliters of cleansed blood per minute per body surface (mL/min/1.73m2)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in calcium as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in total protein as part of comprehensive metabolic panel (CMP)
Unit of measurement - Grams Per Deciliter (g/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in albumin as part of comprehensive metabolic panel (CMP)
Unit of measurement - Grams Per Deciliter (g/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in total bilirubin as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in aspartate transaminase (AST) as part of comprehensive metabolic panel (CMP)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in alanine transaminase (ALT) as part of comprehensive metabolic panel (CMP)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in alkaline phosphatase (ALP) as part of comprehensive metabolic panel (CMP)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in phosphorus as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Longitudinal change in glucose as part of comprehensive metabolic panel (CMP)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.