Trial Outcomes & Findings for Study of Sulphoraphane in Chronic Kidney Disease (NCT NCT05153174)
NCT ID: NCT05153174
Last Updated: 2024-08-12
Results Overview
Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Results posted on
2024-08-12
Participant Flow
1 patient was withdrawn for screen failure before randomizing to an Arm.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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sulphoraphane in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
2 Tablets of Sulforaphane
n=9 Participants
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.
|
4 Tablets of Sulforaphane
n=9 Participants
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.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 10.3327359445 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11.1698447661 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 10.256793556417 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Glutathione S-Transferase Mu 1 (GSTM1) Genotype
GSTM1 (1/1 or 1/0) Allele
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Glutathione S-Transferase Mu 1 (GSTM1) Genotype
GSTM1 (0/0) Null
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Stage of Chronic Kidney Disease (CKD)
Stage 3 CKD (eGFR 30-59)
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Stage of Chronic Kidney Disease (CKD)
Stage 4 CKD (eGFR 15-29)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR) level at Baseline
|
33.3 mL/min/1.73 m2
n=5 Participants
|
34.6 mL/min/1.73 m2
n=7 Participants
|
34.2 mL/min/1.73 m2
n=5 Participants
|
PRIMARY outcome
Timeframe: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dosePopulation: First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification.
Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.
Outcome measures
| Measure |
2 Tablets of Sulforaphane
n=7 Participants
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.
|
4 Tablets of Sulforaphane
n=7 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
|
700.0 nmol h/L
Standard Deviation 376.5
|
718.4 nmol h/L
Standard Deviation 335.8
|
PRIMARY outcome
Timeframe: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dosePopulation: First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification.
Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.
Outcome measures
| Measure |
2 Tablets of Sulforaphane
n=7 Participants
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.
|
4 Tablets of Sulforaphane
n=7 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
|
12497.0 nmol h/L
Standard Deviation 9569.2
|
24928.8 nmol h/L
Standard Deviation 23028.8
|
PRIMARY outcome
Timeframe: day 7Adverse Event is any side effect outside of the subject's baseline.
Outcome measures
| Measure |
2 Tablets of Sulforaphane
n=9 Participants
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.
|
4 Tablets of Sulforaphane
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With an Adverse Event
|
5 Participants
|
7 Participants
|
Adverse Events
2 Tablets of Sulforaphane
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
4 Tablets of Sulforaphane
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 Tablets of Sulforaphane
n=9 participants at risk
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.
|
4 Tablets of Sulforaphane
n=9 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
44.4%
4/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
|
Gastrointestinal disorders
Diarrhea, or Loose Stool
|
22.2%
2/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
22.2%
2/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
|
Gastrointestinal disorders
Flatus (Gas)
|
11.1%
1/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
33.3%
3/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
|
Gastrointestinal disorders
Bloated Stomach
|
0.00%
0/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
33.3%
3/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
|
Gastrointestinal disorders
Heartburn/Reflux
|
0.00%
0/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
22.2%
2/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
|
Gastrointestinal disorders
Indigestion/Abdominal Pain
|
11.1%
1/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
33.3%
3/9 • 10 months, 11 days
Health symptoms that differ from the individual's baseline. Anticipated AE's include gastrointestinal symptoms.
|
Additional Information
Dr Thu H. Le, MD, FAHA - Chief of Nephrology
University of Rochester Medical Center
Phone: 585-273-4259
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place