Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-30 @ 6:33 AM
Study NCT ID:
NCT01324934
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2011-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Recruitment became very slow.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-30', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections', 'timeFrame': '1 year'}, {'measure': 'Incidence and duration of initial DGF', 'timeFrame': '1 year'}, {'measure': 'Renal function', 'timeFrame': '1 year'}, {'measure': 'Patient and Graft survival', 'timeFrame': '1 year'}, {'measure': 'Safety endpoints are the incidence of AEs/SAEs and ADRs', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute rejection', 'chronic rejection', 'subclinical rejection', 'renal transplantation', 'steroid-free', 'kidney transplantation'], 'conditions': ['Renal Transplant Rejection']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Signed and dated informed consent form,\n* End-stage renal disease,\n* Candidates for a first transplantation,\n* Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,\n* Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,\n* Male or female patients between 18 to 75 years of age inclusive,\n* Patients able to comply with all study related requirements,\n* Patients able to receive oral medication,\n* Women of childbearing age with a safe contraceptive method throughout the study.\n\nExclusion Criteria\n\n* Women who are pregnant or breast feeding,\n* Known Human Immunodeficiency Virus,\n* Hepatitis B Virus or Hepatitis C Virus infection,\n* Severe actual viral, bacterial or fungal infection not adequately controlled,\n* Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,\n* Patients at high immunological risk defined as current PRA \\> 25% or historical PRA \\> 50%,\n* Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,\n* Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),\n* Patients with previous transplantation except 1st graft loss due to surgical complications,\n* Patients receiving combined transplantation,\n* Patients with major organ dysfunctions,\n* Serious psychiatric or psychological disorders,\n* Pre-transplant thrombocytopenia: \\< 50,000 thrombocytes/µl, Pre-transplant leukopenia: \\< 2,000 leukocytes/µl,\n* Unable or unwilling to comply fully with the protocol,\n* Participation in another study of an investigational medicinal product concurrently or within the last 30 days.'}, 'identificationModule': {'nctId': 'NCT01324934', 'acronym': 'IBERICA', 'briefTitle': 'Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neovii Biotech'}, 'officialTitle': 'Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression', 'orgStudyIdInfo': {'id': 'AP-AS-24-ES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group', 'description': 'immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic', 'interventionNames': ['Drug: ATG-Fresenius S']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids.'}], 'interventions': [{'name': 'ATG-Fresenius S', 'type': 'DRUG', 'description': 'Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.\n\n(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2799-523', 'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Lisboa Ocidental', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1069-166', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Curry Cabral', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4090-001', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital Geral de Santo António, SA', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario Juan Canalejo', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Clinic i Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosptial Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Manuel Rengel, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hosptial Gregorio Maranon, Madrid, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neovii Biotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurotrials Brasil Consultores Cientificos Ltda', 'class': 'INDUSTRY'}, {'name': 'Recerca Clínica S.L.', 'class': 'INDUSTRY'}, {'name': 'PsyConsult', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}