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

NCT ID: NCT05653492

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Pediatric Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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)

Group Type ACTIVE_COMPARATOR

Sulforaphane

Intervention Type DRUG

Dosing study one to four 30 mg/d tablets depending on weight

Group 2

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)

Group Type ACTIVE_COMPARATOR

Sulforaphane

Intervention Type DRUG

Dosing study one to four 30 mg/d tablets depending on weight

Group 3

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)

Group Type ACTIVE_COMPARATOR

Sulforaphane

Intervention Type DRUG

Dosing study one to four 30 mg/d tablets depending on weight

Interventions

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Sulforaphane

Dosing study one to four 30 mg/d tablets depending on weight

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renal Research Institute

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Levy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00007450

Identifier Type: -

Identifier Source: org_study_id

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