Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT03415750
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2016-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Left Ventricular Hypertrophy', 'timeFrame': '12 months', 'description': 'Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal transplant'], 'conditions': ['Hypertrophy, Left Ventricular']}, 'descriptionModule': {'briefSummary': 'Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.', 'detailedDescription': 'A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's signed informed consent prior to any study-related procedure.\n* Adult patients (\\> 18 years), renal transplant recipients of more than 1 year of evolution.\n* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.\n* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.\n* Subjects with glomerular filtration rate \\>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \\<20%).\n* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \\> 0.5 g/day)\n* Patients with Hb levels ≥ 11 gr/dl.\n* Patients with blood pressure \\<140/90 mmHg in the hospital visits or \\<135/85 mmHg at home.\n\nExclusion Criteria:\n\n* Patient's signed informed consent prior to any study-related procedure.\n* Adult patients (\\> 18 years), renal transplant recipients of more than 1 year of evolution.\n* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.\n* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.\n* Subjects with glomerular filtration rate \\>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \\<20%).\n* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \\> 0.5 g/day)\n* Patients with Hb levels ≥ 11 gr/dl.\n* Patients with blood pressure \\<140/90 mmHg in the hospital visits or \\<135/85 mmHg at home."}, 'identificationModule': {'nctId': 'NCT03415750', 'acronym': 'ENHVIE', 'briefTitle': 'Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'ENHVIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus arm', 'description': "Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'", 'interventionNames': ['Drug: Everolimus', 'Drug: Tacrolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mycophenolate arm', 'description': 'Patients will remain in Tacrolimus + Mycophenolate mofetil combination', 'interventionNames': ['Drug: Mycophenolate mofetil', 'Drug: Tacrolimus']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certican'], 'description': 'Conversion from Mycophenolate mofetil to Everolimus', 'armGroupLabels': ['Everolimus arm']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': 'Patients will remain in Tacrolimus + Mycophenolate mofetil', 'armGroupLabels': ['Mycophenolate arm']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf'], 'armGroupLabels': ['Everolimus arm', 'Mycophenolate arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Edoardo Melilli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edoardo Melilli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator MD', 'investigatorFullName': 'Edoardo Melilli', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}