Chronic Kidney Disease stage3Phase 1NCT05153174

Study of Sulphoraphane in Chronic Kidney Disease

A Phase 1 study testing Sulforaphane in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
What is being tested?: Sulforaphane
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 2 May 2022to 8 Jun 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

eGFR ≥ 20 and <60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane
stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
able to provide consent
able to swallow capsules

Who cannot join

significant co-morbid conditions with life expectancy of <1 year
uncontrolled hypertension
serum potassium of >5.5 mEq/L at screening
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
factors judged to limit adherence to interventions
current participation in another study

Show all 10Show fewer

pregnancy or planning to become pregnant or currently breastfeeding
history of dementia
on anticoagulants or immunosuppression
under treatment for cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease

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.

Read the detailed description

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.

Conditions: Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Being tested: Sulforaphane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SulforaphaneDrug
Also called Avmacol
This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Study groups in NCT05153174
Study group	Role	What they receive
2 tablets of Sulforaphane	Experimental	Participants will be given 2 extra strength tablets per day Receives: Drug: Sulforaphane
4 tablets of Sulforaphane	Experimental	Participants will be given 4 extra strength tablets per day Receives: Drug: Sulforaphane

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20228 Jun 2023

First posted10 Dec 2021
Study start2 May 2022
Primary completion25 May 2023
Study completion8 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05153174
Sponsor's protocol ID: STUDY00006759
Other IDs: 1R01DK128677-01
Status last verified: Aug 2024
First submitted: 29 Nov 2021
Last updated: 12 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD will be shared after publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4

All Chronic Kidney Disease stage3 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05153174
Acronym / sponsor ID: STUDY00006759
Conditions: Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 2 May 2022 (actual)
Primary completion: 25 May 2023 (actual)
Study completion: 8 Jun 2023 (actual)
First posted: 10 Dec 2021 (actual)
Results: Posted 12 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
2 tablets of Sulforaphane	Experimental	Drug: SulforaphaneParticipants will be given 2 extra strength tablets per day
4 tablets of Sulforaphane	Experimental	Drug: SulforaphaneParticipants will be given 4 extra strength tablets per day

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

eGFR ≥ 20 and <60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane
stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
able to provide consent
able to swallow capsules

Key exclusion criteria (10 listed)

significant co-morbid conditions with life expectancy of <1 year
uncontrolled hypertension
serum potassium of >5.5 mEq/L at screening
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
factors judged to limit adherence to interventions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SulforaphaneAlso: AvmacolThis is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.	Drug	2 tablets of Sulforaphane, 4 tablets of Sulforaphane

Primary outcome

Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma
Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.
Area Under the Concentration-Time Curve (AUC 0-8h) in Urine
Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose
Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.
Number of Participants With an Adverse Event
Time frame: day 7
Adverse Event is any side effect outside of the subject's baseline.

Results and safety

Results posted to the registry on 12 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Tablets of Sulforaphane	9	9
4 Tablets of Sulforaphane	9	9

Primary outcome: Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma

Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose. Mean (Standard Deviation). Unit: nmol h/L

Measure	2 Tablets of Sulforaphane n = 7	4 Tablets of Sulforaphane n = 7
Value	700.0 (376.5)	718.4 (335.8)

2 Tablets of Sulforaphane vs 4 Tablets of Sulforaphane: p = 0.931, t-test, 2 sided

Population analysed: First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification.

Primary outcome: Area Under the Concentration-Time Curve (AUC 0-8h) in Urine

Time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose. Mean (Standard Deviation). Unit: nmol h/L

Measure	2 Tablets of Sulforaphane n = 7	4 Tablets of Sulforaphane n = 7
Value	12497.0 (9569.2)	24928.8 (23028.8)

2 Tablets of Sulforaphane vs 4 Tablets of Sulforaphane: p = 0.224, t-test, 2 sided

Population analysed: First 6 samples (2 from each arm) not included due to problem with standards resulting in no absolute quantification.

Primary outcome: Number of Participants With an Adverse Event

Time frame: day 7. Count of participants. Unit: Participants

Measure	2 Tablets of Sulforaphane n = 9	4 Tablets of Sulforaphane n = 9
Value	5	7

Adverse events

Time frame: 10 months, 11 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Tablets of Sulforaphane	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
4 Tablets of Sulforaphane	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD will be shared after publication

Related trials for Chronic Kidney Disease stage3

Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thu H Le, MD, FAHA principal investigator

Division of Nephrology Chief

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sulforaphane in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma (time frame: prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.