Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT01802268
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2013-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-27', 'studyFirstSubmitDate': '2013-02-22', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal Function calculated using the 4 variable MDRD formula', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.', 'timeFrame': '24 months'}, {'measure': 'Incidence of all treated acute rejections.', 'timeFrame': '24 months'}, {'measure': 'Incidence and severity of all tBCAR.', 'timeFrame': '24 months'}, {'measure': 'Patient and graft survival.', 'timeFrame': '24 months'}, {'measure': 'Incidence of treatment discontinuation', 'timeFrame': '24 months'}, {'measure': 'Incidence of adverse events.', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sirolimus', 'tacrolimus', 'early conversion'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.\n\nThis multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years,\n* recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,\n* patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,\n* all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.\n\nExclusion Criteria:\n\n* patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,\n* patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,\n* patients with previous history of malignancy,\n* patients with significant hematological or metabolic laboratorial abnormalities.'}, 'identificationModule': {'nctId': 'NCT01802268', 'briefTitle': 'Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Rim e Hipertensão'}, 'officialTitle': 'Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': '0468E8-3328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus', 'description': 'Conversion from Tacrolimus to Sirolimus', 'interventionNames': ['Drug: Conversion from Tacrolimus to Sirolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus', 'description': 'Maintenance on tacrolimus', 'interventionNames': ['Drug: Maintenance on tacrolimus']}], 'interventions': [{'name': 'Conversion from Tacrolimus to Sirolimus', 'type': 'DRUG', 'armGroupLabels': ['Sirolimus']}, {'name': 'Maintenance on tacrolimus', 'type': 'DRUG', 'armGroupLabels': ['Tacrolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04038', 'city': 'São Jose Do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil'}, {'zip': '04038', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04038', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Helio T. Silva Junior, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}, {'name': 'Claudia R. Felipe, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}, {'name': 'Valter D. Garcia, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil'}, {'name': 'Elias D. Neto, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil'}, {'name': 'Mario A. Filho, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil'}, {'name': 'Fabiana LC Cortieri, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil'}, {'name': 'Deise BM Carvalho, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil'}, {'name': 'Jose OM Pestana, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helio Tedesco Silva Junior', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Helio Tedesco Silva Junior', 'investigatorAffiliation': 'Hospital do Rim e Hipertensão'}}}}