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

Pediatric Kidney Disease Clinical Trial

Official title:

Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653492
• Other study ID #: STUDY00007450
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: Rebecca Levy, MD
• Phone: 585-276-5341
• Email: Rebecca_levy[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Pediatric Kidney Disease

Intervention

Drug:
• Sulforaphane
Dosing study one to four 30 mg/d tablets depending on weight

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean half life of drug in blood		8 hours
Primary	mean maximum concentration of drug in blood		8 hours
Primary	mean area under the curve of drug concentration in blood		8 hours