Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 8:54 AM
Study NCT ID:
NCT05653492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C016766', 'term': 'sulforaphane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean half life of drug in blood', 'timeFrame': '8 hours'}, {'measure': 'mean maximum concentration of drug in blood', 'timeFrame': '8 hours'}, {'measure': 'mean area under the curve of drug concentration in blood', 'timeFrame': '8 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Kidney Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of chronic of kidney disease\n* have eGFR 20-59 mL/min/1.73m2 at the time of enrollment\n* parents must be able to provide consent\n\nExclusion Criteria:\n\n* weight \\<30 kg\n* cancer or HIV diagnosis\n* history of solid organ transplantation (including kidney transplant)\n* structural heart disease\n* currently pregnant or plan to become pregnant\n* life expectancy is less than one year\n* Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics'}, 'identificationModule': {'nctId': 'NCT05653492', 'briefTitle': 'Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Safety, Feasibility, and Tolerability of Sulforaphane in Children with CKD', 'orgStudyIdInfo': {'id': 'STUDY00007450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '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)', 'interventionNames': ['Drug: Sulforaphane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '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)', 'interventionNames': ['Drug: Sulforaphane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '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)', 'interventionNames': ['Drug: Sulforaphane']}], 'interventions': [{'name': 'Sulforaphane', 'type': 'DRUG', 'description': 'Dosing study one to four 30 mg/d tablets depending on weight', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renal Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rebecca Levy', 'investigatorAffiliation': 'University of Rochester'}}}}