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NCT Number: NCT05653492

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pediatric Kidney Disease

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulforaphane

Drug

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

Primary outcomes

  1. mean half life of drug in blood

    Time frame: 8 hours

  2. mean maximum concentration of drug in blood

    Time frame: 8 hours

  3. mean area under the curve of drug concentration in blood

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Renal Research Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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