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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK128677-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 tablets of Sulforaphane | Experimental | Participants will be given 2 extra strength tablets per day |
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| 4 tablets of Sulforaphane | Experimental | Participants will be given 4 extra strength tablets per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane | Drug | This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma | Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours. | prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose |
| Area Under the Concentration-Time Curve (AUC 0-8h) in Urine | Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours. | prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose |
| Number of Participants With an Adverse Event | Adverse Event is any side effect outside of the subject's baseline. | day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thu H Le, MD, FAHA | Division of Nephrology Chief | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
IPD will be shared after publication
May 2024 data is available. End date to be determined.
clinicaltrials.gov
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1 patient was withdrawn for screen failure before randomizing to an Arm. eGFR (Estimated Glomerular Filtration Rate) lab value was stable & out of eligibility range. 2 patients were randomized to a 6-tablet Arm which was removed in the final Protocol Amendment due to moderate side effects.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 Tablets of Sulforaphane | Participants will be given 2 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
| FG001 | 4 Tablets of Sulforaphane | Participants will be given 4 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 Tablets of Sulforaphane | Participants will be given 2 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
| BG001 | 4 Tablets of Sulforaphane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma | Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours. | First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification. | Posted | Mean | Standard Deviation | nmol h/L | prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose |
|
10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
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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 | 2 Tablets of Sulforaphane | Participants will be given 2 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
At the time of review with the Data Safety Monitoring Committee, the study had consented 21 patients and enrolled 18 patients out of 24 targeted. 2 of the 21 patients were randomized to a 6-tablet Arm, which was removed in the final Protocol Amendment due to moderate side effects/adverse events. 1 patient withdrew before study procedures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Thu H. Le, MD, FAHA - Chief of Nephrology | University of Rochester Medical Center | 585-273-4259 | thu_le@urmc.rochester.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 | Nov 17, 2022 | Apr 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2022 | Apr 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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Participants will be given 4 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Glutathione S-Transferase Mu 1 (GSTM1) Genotype | Collection by buccal swab. GSTM1(0/0) Null genotype compared to those carrying the active GSTM1 (1/1 or 1/0) allele. | Count of Participants | Participants |
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| Stage of Chronic Kidney Disease (CKD) | eGFR=Estimated Glomerular Filtration Rate, based on Creatinine level. | Count of Participants | Participants |
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| Estimated Glomerular Filtration Rate (eGFR) level at Baseline | Mean | Full Range | mL/min/1.73 m2 |
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| Primary | Area Under the Concentration-Time Curve (AUC 0-8h) in Urine | Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours. | First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification. | Posted | Mean | Standard Deviation | nmol h/L | prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose |
|
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| Primary | Number of Participants With an Adverse Event | Adverse Event is any side effect outside of the subject's baseline. | Posted | Count of Participants | Participants | day 7 |
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| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | 4 Tablets of Sulforaphane | Participants will be given 4 extra strength tablets per day Sulforaphane: This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets. | 0 | 9 | 0 | 9 | 7 | 9 |
| Diarrhea, or Loose Stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatus (Gas) | Gastrointestinal disorders | Non-systematic Assessment |
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| Bloated Stomach | Gastrointestinal disorders | Non-systematic Assessment |
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| Heartburn/Reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| Indigestion/Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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