University of Rochester Medical Center
Rochester, New York, 14642, United States
NCT Number: NCT05797506
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, Month 1, Month 3, and Month 6
Plasma 8 isoprostane in picograms per milliliter was measured at baseline and at Months 1, 3, and 6. For each participant at each follow up visit, change from baseline was calculated as follow up value minus baseline value. Mean change and standard deviation are reported separately at Month 1, Month 3, and Month 6.
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - μg/ml
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - milligram per gram (mg/g)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - microgram per milliliter μg/mL
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Relative copy number
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Relative copy number
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Millimoles per liter (mmol/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - milliequivalents per liter (mEq/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
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)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Grams Per Deciliter (g/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Grams Per Deciliter (g/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - units per liter (U/L)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Milligrams per decilitre (mg/dL)
Time frame: Four timepoints per patient (baseline, month 1, month 3, and month 6)
Unit of measurement - Milligrams per decilitre (mg/dL)
University of Rochester
Other
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease - Randomized, Double-blind, Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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