Trial Outcomes & Findings for Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease (NCT NCT05797506)
NCT ID: NCT05797506
Last Updated: 2026-05-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline, Month 1, Month 3, and Month 6
Results posted on
2026-05-18
Participant Flow
Participant milestones
| Measure |
Sulforaphane (Avmacol Extra Strength)
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
|
Placebo
Nutramax will provide the matched placebo tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
|
Overall Study
COMPLETED
|
36
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Sulforaphane (Avmacol Extra Strength)
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
|
Placebo
Nutramax will provide the matched placebo tablets.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
Baseline Characteristics
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Sulforaphane (Avmacol Extra Strength)
n=49 Participants
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
|
Placebo
n=47 Participants
Nutramax will provide the matched placebo tablets.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=11 Participants
|
12 Participants
n=9 Participants
|
32 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=11 Participants
|
35 Participants
n=9 Participants
|
64 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=11 Participants
|
18 Participants
n=9 Participants
|
41 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Male
|
26 Participants
n=11 Participants
|
28 Participants
n=9 Participants
|
54 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=11 Participants
|
40 Participants
n=9 Participants
|
80 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=11 Participants
|
46 Participants
n=9 Participants
|
94 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
GSTM1 Genotype
Genotype (1/1) or (1/0)
|
19 Participants
n=11 Participants
|
24 Participants
n=9 Participants
|
43 Participants
n=20 Participants
|
|
GSTM1 Genotype
Genotype (0/0)
|
30 Participants
n=11 Participants
|
23 Participants
n=9 Participants
|
53 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 3, and Month 6Population: All randomized participants with available data at each specific timepoint (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.
Outcome measures
| Measure |
Sulforaphane (Avmacol Extra Strength)
n=49 Participants
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
Sulforaphane (Avmacol Extra Strength): 4 Tablets of Sulforaphane (Avmacol Extra Strength) per day in patients with Chronic Kidney Disease, stages 3-4.
|
Placebo
n=47 Participants
Nutramax will provide the matched placebo tablets.
Placebo: These tablets will be matched placebos and will be provided by Avmacol.
|
|---|---|---|
|
Change in Plasma 8 Isoprostane From Baseline
Month 1
|
19.2 pg/mL
Standard Deviation 121.65
|
35.0 pg/mL
Standard Deviation 129.43
|
|
Change in Plasma 8 Isoprostane From Baseline
Month 3
|
18.1 pg/mL
Standard Deviation 97.73
|
56.3 pg/mL
Standard Deviation 136.69
|
|
Change in Plasma 8 Isoprostane From Baseline
Month 6
|
14.5 pg/mL
Standard Deviation 113.38
|
-1.7 pg/mL
Standard Deviation 98.07
|
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - μg/ml
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - milligram per gram (mg/g)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - microgram per milliliter μg/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Relative copy number
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Relative copy number
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Millimoles per liter (mmol/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Millimoles per liter (mmol/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Millimoles per liter (mmol/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Millimoles per liter (mmol/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - milliequivalents per liter (mEq/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Grams Per Deciliter (g/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Grams Per Deciliter (g/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - units per liter (U/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - units per liter (U/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - units per liter (U/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four timepoints per patient (baseline, month 1, month 3, and month 6)Unit of measurement - Milligrams per decilitre (mg/dL)
Outcome measures
Outcome data not reported
Adverse Events
Sulforaphane (Avmacol Extra Strength)
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulforaphane (Avmacol Extra Strength)
n=49 participants at risk
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
|
Placebo
n=47 participants at risk
Nutramax will provide the matched placebo tablets.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.0%
1/49 • 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.
|
0.00%
0/47 • 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.
|
Other adverse events
| Measure |
Sulforaphane (Avmacol Extra Strength)
n=49 participants at risk
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
|
Placebo
n=47 participants at risk
Nutramax will provide the matched placebo tablets.
|
|---|---|---|
|
Gastrointestinal disorders
Eructation (burping)
|
6.1%
3/49 • 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.
|
2.1%
1/47 • 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.
|
|
Gastrointestinal disorders
Urgency/Increased Frequency for Bowel Movement
|
2.0%
1/49 • 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.
|
6.4%
3/47 • 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.
|
|
Gastrointestinal disorders
Reflux
|
6.1%
3/49 • 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.
|
0.00%
0/47 • 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.
|
|
Immune system disorders
Illness, Infection, Viral Gastroenteritis
|
6.1%
3/49 • 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.
|
6.4%
3/47 • 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.
|
|
Gastrointestinal disorders
Bloating
|
8.2%
4/49 • 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.
|
2.1%
1/47 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
8.2%
4/49 • 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.
|
8.5%
4/47 • 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.
|
|
Gastrointestinal disorders
Loose Stool
|
2.0%
1/49 • 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.
|
6.4%
3/47 • 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.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
2/49 • 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.
|
8.5%
4/47 • 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.
|
|
Gastrointestinal disorders
Flatus (gas in or from the stomach or intestine)
|
24.5%
12/49 • 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.
|
25.5%
12/47 • 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.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
5/49 • 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.
|
4.3%
2/47 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain/Cramping
|
8.2%
4/49 • 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.
|
2.1%
1/47 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place