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

Primary Purpose

Pediatric Kidney Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sulforaphane
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Kidney Disease

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

mean half life of drug in blood
mean maximum concentration of drug in blood
mean area under the curve of drug concentration in blood

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
August 8, 2023
Sponsor
University of Rochester
Collaborators
Renal Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05653492
Brief Title
Safety, Feasibility, and Tolerability of Sulforaphane in Children With Chronic Kidney Disease
Official Title
Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Renal Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Sulforaphane
Intervention Description
Dosing study one to four 30 mg/d tablets depending on weight
Primary Outcome Measure Information:
Title
mean half life of drug in blood
Time Frame
8 hours
Title
mean maximum concentration of drug in blood
Time Frame
8 hours
Title
mean area under the curve of drug concentration in blood
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Levy, MD
Phone
585-276-5341
Email
Rebecca_levy@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Levy, MD
Phone
585-276-5341
Email
rebecca_levy@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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