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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK128677 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| Nutramax Laboratories, Inc. | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane (Avmacol Extra Strength) | Experimental | Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. |
|
| Placebo | Placebo Comparator | Nutramax will provide the matched placebo tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane (Avmacol Extra Strength) | Drug | 4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma 8 Isoprostane From Baseline | 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. | Baseline, Month 1, Month 3, and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Change in Urinary Albumin | Unit of measurement - μg/ml | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulforaphane (Avmacol Extra Strength) | Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. |
| FG001 | Placebo | Nutramax will provide the matched placebo tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane (Avmacol Extra Strength) | Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. |
| BG001 | Placebo | Nutramax will provide the matched placebo tablets. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma 8 Isoprostane From Baseline | 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. | All randomized participants with available data at each specific timepoint (baseline, month 1, month 3, and month 6) | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 1, Month 3, and Month 6 |
|
From enrollment through Month 6
Adverse events were collected at each study visit (Baseline, Month 1, Month 3, and Month 6) and during interim phone calls (Months 2, 4, and 5) through systematic assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulforaphane (Avmacol Extra Strength) | Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain/Cramping | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thu H. Le, MD, FAHA | University of California, Irvine | 714-456-3224 | thuhl@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2025 | Feb 3, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2025 | Feb 3, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Placebo | Dietary Supplement | These tablets will be matched placebos and will be provided by Avmacol. |
|
| 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Four timepoints per patient (baseline, month 1, month 3, and month 6) |
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| GSTM1 Genotype | GSTM1 genotype determined from buccal swab; categorized based on gene deletion status | Count of Participants | Participants |
|
| OG001 | Placebo | Nutramax will provide the matched placebo tablets. Placebo: These tablets will be matched placebos and will be provided by Avmacol. |
|
|
| Secondary | Longitudinal Change in Urinary Albumin | Unit of measurement - μg/ml | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Protein/Creatinine Ratio | Unit of measurement - milligram per gram (mg/g) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Urine Nephrin | Unit of measurement - microgram per milliliter μg/mL | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Messenger RNA (mRNA) Levels of Cytoprotective Enzymes in Peripheral Blood Mononuclear Cells (PBMCs) | Unit of measurement - Relative copy number | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Messenger RNA (mRNA) Levels of Heat Shock Proteins in Peripheral Blood Mononuclear Cells (PBMCs) | Unit of measurement - Relative copy number | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Sodium as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Millimoles per liter (mmol/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Potassium as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Millimoles per liter (mmol/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Chloride as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Millimoles per liter (mmol/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Carbon Dioxide as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Millimoles per liter (mmol/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Anion Gap as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - milliequivalents per liter (mEq/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Blood Urea Nitrogen as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Creatinine as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | 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) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Calcium as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Total Protein as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Grams Per Deciliter (g/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Albumin as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Grams Per Deciliter (g/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Total Bilirubin as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Aspartate Transaminase (AST) as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - units per liter (U/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Alanine Transaminase (ALT) as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - units per liter (U/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Alkaline Phosphatase (ALP) as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - units per liter (U/L) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Phosphorus as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| Secondary | Longitudinal Change in Glucose as Part of Comprehensive Metabolic Panel (CMP) | Unit of measurement - Milligrams per decilitre (mg/dL) | Not Posted | Four timepoints per patient (baseline, month 1, month 3, and month 6) | Participants |
| 0 |
| 49 |
| 1 |
| 49 |
| 39 |
| 49 |
| EG001 | Placebo | Nutramax will provide the matched placebo tablets. | 0 | 47 | 0 | 47 | 34 | 47 |
| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Flatus (gas in or from the stomach or intestine) | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Eructation (burping) | Gastrointestinal disorders | Systematic Assessment |
|
| Urgency/Increased Frequency for Bowel Movement | Gastrointestinal disorders | Systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Illness, Infection, Viral Gastroenteritis | Immune system disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |