Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01468051
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2011-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-11-20', 'releaseDate': '2014-11-15'}], 'estimatedResultsFirstSubmitDate': '2014-11-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-10-27', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatitis B surface antibody mIU/ml', 'timeFrame': '8-10 weeks after the 6-month dose of vaccine', 'description': 'Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['predialysed', 'chronic', 'renal failure patients'], 'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination.\n\nIn this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.', 'detailedDescription': 'In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* predialysis patients,\n* \\> 18 years with mild and moderate chronic renal failure,\n* serum creatinine between 1.5-6 mg/dl\n\nExclusion Criteria:\n\n* patients with severe renal failure,\n* serum creatinine \\> 6 mg/dl,\n* requiring dialysis or expected to require dialysis within 1 year,\n* receiving immunosuppressive treatment,\n* known lymphoproliferative disorder.'}, 'identificationModule': {'nctId': 'NCT01468051', 'briefTitle': 'Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients', 'orgStudyIdInfo': {'id': '507'}, 'secondaryIdInfos': [{'id': '507', 'type': 'OTHER', 'domain': 'Tehran University of Medical Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '40 μg (2 ml) four doses of Euvax B vaccine', 'description': '40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)', 'interventionNames': ['Biological: four doses of Euvax B vaccine']}, {'type': 'EXPERIMENTAL', 'label': '20 μg (1 ml) three doses of Euvax B vaccine', 'description': '20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)', 'interventionNames': ['Biological: 20 μg (1 ml) three doses of Euvax B vaccine']}], 'interventions': [{'name': 'four doses of Euvax B vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)'], 'description': '40 μg (2 ml) four doses of Euvax B vaccine', 'armGroupLabels': ['40 μg (2 ml) four doses of Euvax B vaccine']}, {'name': '20 μg (1 ml) three doses of Euvax B vaccine', 'type': 'BIOLOGICAL', 'description': '20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)', 'armGroupLabels': ['20 μg (1 ml) three doses of Euvax B vaccine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital.', 'investigatorFullName': 'Zahra Khazaeipour', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-11-15', 'type': 'RELEASE'}, {'date': '2014-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zahra Khazaeipour, Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital., Tehran University of Medical Sciences'}}}}