Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-25 @ 12:53 AM
Study NCT ID:
NCT00994305
Status:
UNKNOWN
Last Update Posted:
2009-10-14
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'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'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2009-10-09', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Graft function: measure of serum creatinine', 'timeFrame': '3 months'}, {'measure': 'Graft function:estimated creatinine clearance by Cokcroft-Gault formula', 'timeFrame': '3 months'}, {'measure': 'Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney transplantation', 'oxidative stress', 'acetylcysteine', 'graft rejection'], 'conditions': ['Renal Transplantation']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Danilovic A, Lucon AM, Seguro AC, Shimizu MHM, Ianhez LE, Nahas WC, Srougi M. N-acetylcysteine attenuates oxidative stress in deceased renal transplantation. The Journal of Urology 181 (4): 740; 2009.'}]}, 'descriptionModule': {'briefSummary': 'Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.', 'detailedDescription': 'Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.\n\nAdult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary deceased renal transplant recipients\n* adult (\\>18 yo)\n\nExclusion Criteria:\n\n* unable to drink N-acetylcysteine during the first 7 PO\n* participation in other study'}, 'identificationModule': {'nctId': 'NCT00994305', 'acronym': 'NACTX', 'briefTitle': 'Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant', 'orgStudyIdInfo': {'id': 'NACTX'}, 'secondaryIdInfos': [{'id': 'FAPESP 06/52046-0'}, {'id': 'CAPPesq 076/05'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetylcysteine', 'description': 'N-acetylcysteine 600 mg bid po 0-7 PO', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'No treatment: standard care provided. No N-acetylcysteine administration.', 'interventionNames': ['Drug: control']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['Fluimucil'], 'description': '600 mg bid po 0-7 PO', 'armGroupLabels': ['N-acetylcysteine']}, {'name': 'control', 'type': 'DRUG', 'otherNames': ['N/A (not applicable)'], 'description': 'No treatment: standard care provided. No N-acetylcysteine administration.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo General Hospital Kidney Transplant Unit', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexandre Danilovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'ANTONIO MARMO LUCON', 'oldOrganization': 'University of Sao Paulo Medical School'}}}}