Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 12:03 PM
Study NCT ID:
NCT01028092
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'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': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculated renal function with MDRD equation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Acute rejection rate', 'timeFrame': '12 months'}, {'measure': 'Patient and graft survival rate', 'timeFrame': '12 months'}, {'measure': 'Adverse events', 'timeFrame': '12 months'}, {'measure': 'GFR calculated with Cockcroft Gault formula', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Transplant']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (\\>60 years old) recipients receiving graft from elderly donor(\\>60 years old).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has given written informed consent to participate in the study\n* First or second single transplantation of a recipient (male or female) older than 60 years old\n* Donor older than 60 years old\n* PRA \\< 30%\n\nExclusion Criteria:\n\n* Living donor\n* Third transplantation\n* PRA \\> 30%\n\nOther protocol-defined inclusion/exclusion criteria may apply.\n\n* Recipient of multi-organ transplant\n* Active major infections (HBV, HCV, HIV)\n* Loss of a first graft for immunologic issues\n* Anemia (\\<9g/l) or leucopenia (\\<2500/mm3)'}, 'identificationModule': {'nctId': 'NCT01028092', 'acronym': 'EVEROLD', 'briefTitle': 'mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation', 'orgStudyIdInfo': {'id': 'EVEROLD'}, 'secondaryIdInfos': [{'id': 'RB 09.074'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids', 'interventionNames': ['Drug: Anti R-IL2 + Cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'CNI-free', 'description': 'Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids', 'interventionNames': ['Drug: Thymoglobulin + Everolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Switch', 'description': 'anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids', 'interventionNames': ['Drug: Anti R-IL2 + Cyclosporine then Everolimus']}], 'interventions': [{'name': 'Anti R-IL2 + Cyclosporine', 'type': 'DRUG', 'description': '* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)\n* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0\n* cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2\n* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6', 'armGroupLabels': ['Control']}, {'name': 'Thymoglobulin + Everolimus', 'type': 'DRUG', 'description': '* Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days\n* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0\n* everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml\n* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6', 'armGroupLabels': ['CNI-free']}, {'name': 'Anti R-IL2 + Cyclosporine then Everolimus', 'type': 'DRUG', 'description': '* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)\n* Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0\n* cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml\n* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6', 'armGroupLabels': ['Switch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin - Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de BREST', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil - Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Yannick LE MEUR, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, {'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}