Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT03978494
Status:
WITHDRAWN
Last Update Posted:
2019-09-17
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'company decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-05-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-τ)ss', 'timeFrame': 'Day 21 of each treatment period', 'description': 'Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state'}, {'measure': 'Cmax,ss', 'timeFrame': 'Day 21 of each treatment period', 'description': 'Maximum whole blood concentration at steady state'}], 'secondaryOutcomes': [{'measure': 'AUC(0-τ)ss', 'timeFrame': 'Day 14 of each treatment period', 'description': 'Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state'}, {'measure': 'Cmax,ss', 'timeFrame': 'Day 14 of each treatment period', 'description': 'Maximum whole blood concentration at steady state'}, {'measure': 'Cmin,ss', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Minimum whole blood concentration at steady state'}, {'measure': 'Cτ,ss', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Concentration at the end of the dosing interval at steady state'}, {'measure': 'Cav', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Average concentration during a dosing interval: AUC(0-τ)/τ'}, {'measure': 'Tmax,ss', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Time to reach maximum (peak) plasma concentration at steady state'}, {'measure': 'AUC(0-τ)ss coefficient of variation', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-τ)ss coefficient of variation'}, {'measure': 'Cmax,ss coefficient of variation', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation'}, {'measure': '% Fluctuation', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Degree of fluctuation of the analyte concentration levels over one dosing interval: 100\\*(Cmax,ss - Cmin,ss)/Cav.'}, {'measure': '%Swing', 'timeFrame': 'Days 14 and 21 of each treatment period', 'description': 'Degree of change of the analyte concentration levels over one dosing interval: 100\\*(Cmax,ss - Cτ,ss)/Cτ,ss.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplant; Renal transplant'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.', 'detailedDescription': 'Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged ≥18 years;\n* Patients with a Body Mass Index (BMI) included in the interval \\[18.5-33.0\\] kg/m²;\n* Patients who received a primary kidney transplant at least 12 months prior to study entry\n\nExclusion Criteria:\n\n* Evidence or suspicion of ongoing or persistent, acute or chronic rejection;\n* Requirement for dialysis within the six months prior to study entry;\n* Glomerular filtration rate (GFR) \\<30 mL/min\n* Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;\n* Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;'}, 'identificationModule': {'nctId': 'NCT03978494', 'acronym': 'TODAY', 'briefTitle': 'Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)', 'orgStudyIdInfo': {'id': '1829-TAC-1'}, 'secondaryIdInfos': [{'id': '2018-002672-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1: Advagraf®; Period 2: Generic tacrolimus', 'description': 'In Period 1 patients will receive branded tacrolimus (Advagraf®) orally once-a-day and in Period 2 patients will receive the generic tacrolimus (Sandoz) orally once-a-day.', 'interventionNames': ['Drug: Advagraf®', 'Drug: Generic tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Period 1: Generic tacrolimus; Period 2: Advagraf®', 'description': 'In Period 1 patients will receive the generic tacrolimus (Sandoz) orally once-a-day and in Period 2 patients will receive branded tacrolimus (Advagraf®) orally once-a-day.', 'interventionNames': ['Drug: Advagraf®', 'Drug: Generic tacrolimus']}], 'interventions': [{'name': 'Advagraf®', 'type': 'DRUG', 'description': 'Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).', 'armGroupLabels': ['Period 1: Advagraf®; Period 2: Generic tacrolimus', 'Period 1: Generic tacrolimus; Period 2: Advagraf®']}, {'name': 'Generic tacrolimus', 'type': 'DRUG', 'description': 'Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)', 'armGroupLabels': ['Period 1: Advagraf®; Period 2: Generic tacrolimus', 'Period 1: Generic tacrolimus; Period 2: Advagraf®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Sandoz Investigative Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Sandoz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sandoz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}