NCT05653492

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

December 7, 2022

Last Update Submit

September 10, 2024

Conditions

Pediatric Kidney Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

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

SulforaphaneDRUG

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

Group 1Group 2Group 3

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

sulforaphane

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 16, 2022

Study Start

May 15, 2023

Primary Completion

April 30, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)