Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-03 @ 1:06 PM
Study NCT ID:
NCT02314312
Status:
UNKNOWN
Last Update Posted:
2014-12-11
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eGFR (CKD-EPI)', 'timeFrame': '12 months post kidney transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney transplantation', 'ECD'], 'conditions': ['Transplantation of Kidney', 'Expanded Criteria Donor', 'ECD']}, 'descriptionModule': {'briefSummary': 'Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation', 'detailedDescription': 'Secondary Endpoints:\n\n* To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation\n* To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation\n* To assess the incidence and duration of renal replacement therapy\n* To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12\n* To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation\n* To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation\n\nDefinition of ECD\n\n* Brain-dead donor \\> 60 years old or\n* Donor age \\> 50 years old with two of the following criteria;\n* History of HT\n* Terminal SCr. ≥ 1.5 mg/dL\n* Death from cerebrovascular accident Definition of AKI donor\n* Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Recipients of first DDKT from ECD or AKI donors\n* Patient willing to participate in the study\n\nExclusion Criteria:\n\n* Multi-organ recipients\n\n * Organ donation after Cardiac Death (DCD).\n * PRA \\> 20 % or with historical peak PRA \\> 50%\n * Patients who lost first graft due to immunological reason within the first year post-transplantation.\n * ABO incompatible transplants or positive cross-match\n * Patients with chronic inflammatory bowel disease.\n * Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin\n * Thrombocytopenia (platelet \\< 75,000/mm3), ANC \\< 1,500 /mm3 or leucopenia (leucocytes \\< 2,500/mm3), or Hb \\< 6 g/dL\n * Chronic active HCV, HIV, or HBsAg positive\n * History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.\n * Ongoing infection requiring treatment with a systemic antibiotic.\n * Patient with severe hypercholesterolemia (\\> 300 mg/dL) or hypertriglyceridemia (\\> 600 mg/dL) that cannot be controlled\n * Evidence of severe liver disease.\n * Severe restrictive or obstructive pulmonary disorders.\n * Pregnant or nursing (lactating) women.\n * Patient who refuse to participate into the study or would like to withdraw from the study.'}, 'identificationModule': {'nctId': 'NCT02314312', 'briefTitle': 'Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'CRAD001ATH01T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: investigation arm', 'description': 'De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen', 'interventionNames': ['Drug: Everolimus + low dose cyclosporin A + prednisolone']}, {'type': 'OTHER', 'label': 'B: control arm', 'description': 'De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen', 'interventionNames': ['Drug: Standard immunosupressive regimen']}], 'interventions': [{'name': 'Everolimus + low dose cyclosporin A + prednisolone', 'type': 'DRUG', 'armGroupLabels': ['A: investigation arm']}, {'name': 'Standard immunosupressive regimen', 'type': 'DRUG', 'armGroupLabels': ['B: control arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Surasak Kantachuvesiri, M.D., PH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ramathibodi Hospital', 'investigatorFullName': 'CHALERMPON NA PETVICHARN', 'investigatorAffiliation': 'Mahidol University'}}}}