Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 6:40 PM
Study NCT ID:
NCT01244659
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'day 1 to day 180', 'description': 'Incidence of biopsy confirmed acute rejection'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'day 1 to day 180', 'description': '1. Patient and graft survival\n2. Renal function control by Estimated Glomerular Filtration Rate\n3. Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tacrolimus', 'Immunosuppressive Agents', 'Kidney transplantation'], 'conditions': ['Renal Transplant']}, 'descriptionModule': {'briefSummary': 'Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 year old\n* Patient is receiving kidney from live or death donor\n* Kidney donor younger than 65 years old\n* PRA ≤ 30%\n* Negative pregnancy test for women\n* Patient agreement to practice birth control\n* Patient has been fully informed and has given written informed consent\n\nExclusion Criteria:\n\n* HLA identical\n* Patient multi-organ transplant recipient\n* Any pathology or past medical condition that can interfere with this protocol\n* Allergy or intolerance of any study medication'}, 'identificationModule': {'nctId': 'NCT01244659', 'briefTitle': 'A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients', 'orgStudyIdInfo': {'id': 'TACEMS0410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus from EMS', 'description': 'Group 1: Tacrolimus from EMS + Myfortic® + Steroids', 'interventionNames': ['Drug: Tacrolimus from EMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prograf', 'description': 'Group 2: Prograf® + Myfortic® + Steroids', 'interventionNames': ['Drug: Prograf']}], 'interventions': [{'name': 'Tacrolimus from EMS', 'type': 'DRUG', 'description': 'Tacrolimus initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.', 'armGroupLabels': ['Tacrolimus from EMS']}, {'name': 'Prograf', 'type': 'DRUG', 'description': 'Prograf initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.', 'armGroupLabels': ['Prograf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90020090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Santa Casa de Misericórdia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Felipe Pinho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}