Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT02500212
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2015-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL', 'timeFrame': 'pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose'}], 'secondaryOutcomes': [{'measure': 'Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL', 'timeFrame': '24.0 hr post-dose', 'description': 'Whole blood trough drug concentration 24hour post dose'}, {'measure': 'Serum creatinine (mg/dL)', 'timeFrame': 'before dosing'}, {'measure': 'estimated glomerular filtration rate (eGFR) mL/min;', 'timeFrame': 'before dosing'}, {'measure': 'Heart Rate, (beats per minute)', 'timeFrame': 'before dosing'}, {'measure': 'Qt (milliseconds)', 'timeFrame': 'before dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Organ or Tissue Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '30552587', 'type': 'RESULT', 'citation': 'Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005572-28', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipients of a kidney transplant from a deceased donor or a living donor\n\nExclusion Criteria:\n\n* Recipient of any transplanted organ other than a kidney;\n* Recipients of a bone marrow or stem cell transplant;\n* Recipients of a kidney from a cardiac death donor;\n* Recipients of a kidney from an ABO incompatible donor;'}, 'identificationModule': {'nctId': 'NCT02500212', 'briefTitle': 'Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS', 'orgStudyIdInfo': {'id': 'CCD-06235AA1-02'}, 'secondaryIdInfos': [{'id': '2014-005572-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ENVARSUS tablets', 'description': 'Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths.\n\nEnvarsus® tablets will be administered orally once daily in the morning', 'interventionNames': ['Drug: ENVARSUS®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ADVAGRAF capsules', 'description': 'Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths.\n\nAdvagraf® capsules will be administered orally once daily in the morning', 'interventionNames': ['Drug: ADVAGRAF®']}], 'interventions': [{'name': 'ENVARSUS®', 'type': 'DRUG', 'armGroupLabels': ['ENVARSUS tablets']}, {'name': 'ADVAGRAF®', 'type': 'DRUG', 'armGroupLabels': ['ADVAGRAF capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '296009', 'city': 'Brest', 'country': 'France', 'facility': 'Nephrology Department Hopital La Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Clinique de Nephrologie CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Service de Nephrologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'Unité de transplantation rénale -Hopital Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Nephrology department CHU de Saint-Etienne Hospital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil, 1 avenue J Poulhes TSA 50032.', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}