Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 1:58 PM
Study NCT ID:
NCT01891292
Status:
UNKNOWN
Last Update Posted:
2013-07-03
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004656', 'term': 'Enalapril'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary albumin excretion rate', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate', 'timeFrame': '12 months', 'description': 'Measurement of glomerular filtration rate by iohexol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Microalbuminuria', 'Sickle Cell Nephropathy']}, 'referencesModule': {'references': [{'pmid': '34932828', 'type': 'DERIVED', 'citation': 'Sasongko TH, Nagalla S. Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD009191. doi: 10.1002/14651858.CD009191.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homozygous S sickle cell disease\n* Diagnosed by newborn screening\n* determined to have persistent microalbuminuria\n* satisfied criteria for microalbuminuria screening\n* parental consent\n\nExclusion Criteria:\n\n* Asymptomatic bacteriuria on screening urine cultures\n* On Hydroxyurea therapy\n* Pre-existing complications of SCD which would meet local criteria for HU therapy'}, 'identificationModule': {'nctId': 'NCT01891292', 'briefTitle': 'Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'The University of The West Indies'}, 'officialTitle': 'A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children', 'orgStudyIdInfo': {'id': 'ECP 172, 10/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'interventionNames': ['Drug: Enalapril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-Acetylcysteine', 'interventionNames': ['Drug: N-Acetylcysteine']}], 'interventions': [{'name': 'Enalapril', 'type': 'DRUG', 'description': '0.25-0.35 mg/kg/day', 'armGroupLabels': ['Enalapril']}, {'name': 'N-Acetylcysteine', 'type': 'DRUG', 'description': 'N-Acetylcysteine 0.5 mmol/kg', 'armGroupLabels': ['N-Acetylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kingston', 'country': 'Jamaica', 'contacts': [{'name': 'Lesley King, MB.BS', 'role': 'CONTACT', 'email': 'lesley.king@uwimona.edu.jm', 'phone': '8769272471'}, {'name': 'Marvin Reid, MB.BS', 'role': 'CONTACT', 'email': 'marvin.reid@uwimona.edu.jm', 'phone': '8769272471'}, {'name': 'Lesley King, MB.BS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sickle Cell Unit', 'geoPoint': {'lat': 17.99702, 'lon': -76.79358}}], 'centralContacts': [{'name': 'Lesley King, MB.BS', 'role': 'CONTACT', 'email': 'lesley.king@uwimona.edu.jm', 'phone': '976-927-2471'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of The West Indies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caribbean Health Research Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marvin Reid', 'investigatorAffiliation': 'The University of The West Indies'}}}}