Pediatric Kidney DiseasePhase 2NCT05653492
Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease
A Phase 2 study testing Sulforaphane in people with Pediatric Kidney Disease, run by University of Rochester at 1 site in United States.
Trial summary
This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Kidney Disease
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of chronic of kidney disease
- have eGFR 20-59 mL/min/1.73m2 at the time of enrollment
- parents must be able to provide consent
Who cannot join
- weight <30 kg
- cancer or HIV diagnosis
- history of solid organ transplantation (including kidney transplant)
- structural heart disease
- currently pregnant or plan to become pregnant
- life expectancy is less than one year
- Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Safety, Feasibility, and Tolerability of Sulforaphane in Children with CKD
This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.
- Conditions
- Pediatric Kidney Disease
- Being tested
- Sulforaphane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDrug
Dosing study one to four 30 mg/d tablets depending on weight
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (60mg/d) 70-90 lbs; 3 tablets (90mg/d) >90 lbs; 4 tablets (120 mg/d) Receives: Drug: Sulforaphane |
| Group 2 | Active comparator | 30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (60mg/d) >90 lbs; 2 tablets (60 mg/d) Receives: Drug: Sulforaphane |
| Group 3 | Active comparator | 30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 1 tablet (30mg/d) >90 lbs; 1 tablet (30 mg/d) Receives: Drug: Sulforaphane |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean half life of drug in blood
Measured: 8 hours
mean maximum concentration of drug in blood
Measured: 8 hours
mean area under the curve of drug concentration in blood
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 May 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Kidney DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Principal investigator, Rebecca Levy, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653492
- Sponsor's protocol ID
- STUDY00007450
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Tolerability of Sulforaphane in Children with CKD
- ClinicalTrials.gov ID
- NCT05653492
- Acronym / sponsor ID
- STUDY00007450
- Conditions
- Pediatric Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Sulforaphane30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (60mg/d) 70-90 lbs; 3 tablets (90mg/d) >90 lbs; 4 tablets (120 mg/d) |
| Group 2 | Active comparator | Drug: Sulforaphane30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (60mg/d) >90 lbs; 2 tablets (60 mg/d) |
| Group 3 | Active comparator | Drug: Sulforaphane30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 1 tablet (30mg/d) >90 lbs; 1 tablet (30 mg/d) |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosis of chronic of kidney disease
- have eGFR 20-59 mL/min/1.73m2 at the time of enrollment
- parents must be able to provide consent
Key exclusion criteria (7 listed)
- weight <30 kg
- cancer or HIV diagnosis
- history of solid organ transplantation (including kidney transplant)
- structural heart disease
- currently pregnant or plan to become pregnant
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 |
|---|---|---|
| SulforaphaneDosing study one to four 30 mg/d tablets depending on weight | Drug | Group 1, Group 2, Group 3 |
Primary outcome
mean half life of drug in blood
Time frame: 8 hours
mean maximum concentration of drug in blood
Time frame: 8 hours
mean area under the curve of drug concentration in blood
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Pediatric Kidney Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulforaphane in people with Pediatric Kidney Disease, 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
mean half life of drug in blood (time frame: 8 hours). 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?
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 19 Sep 2024.