Safety, Feasibility, and Tolerability of Sulforaphane in... | NCT05653492

Studies
Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease

NCT05653492

Sponsor

University of Rochester

Status

Active, not recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

12Estimated

Phase

Phase 2

Conditions

Pediatric Kidney Disease

Interventions

Sulforaphane

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
Renal Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	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)	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)	Drug: Sulforaphane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sulforaphane	Drug	Dosing study one to four 30 mg/d tablets depending on weight	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean half life of drug in blood		8 hours
mean maximum concentration of drug in blood		8 hours
mean area under the curve of drug concentration in blood		8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center		Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 28, 2026			May 19, 2026	5

Intervention Browse Module

MeSH Terms

ID	Term
C016766	sulforaphane

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided