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

Sponsor
University of Rochester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653492
Collaborator
Renal Research Institute (Other)
12
Enrollment
1
Location
3
Arms
6
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (30mg/d) 70-90 lbs; 3 tablets (30mg/d) >90 lbs; 4 tablets (30 mg/d)

Drug: Sulforaphane
Dosing study one to four 30 mg/d tablets depending on weight
Active Comparator: Group 2

30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (30mg/d) >90 lbs; 2 tablets (30 mg/d)

Drug: Sulforaphane
Dosing study one to four 30 mg/d tablets depending on weight
Active Comparator: Group 3

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

Outcome Measures

Primary Outcome Measures

  1. mean half life of drug in blood [8 hours]

  2. mean maximum concentration of drug in blood [8 hours]

  3. mean area under the curve of drug concentration in blood [8 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Medical Center Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester
  • Renal Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebecca Levy, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT05653492
Other Study ID Numbers:
  • STUDY00007450
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Sulforaphane

Study Results

No Results Posted as of Dec 16, 2022