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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653492
Other study ID # STUDY00007450
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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