Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 12:04 AM
Study NCT ID:
NCT01681134
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2012-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2012-09-05', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Renal Plasma Flow (ERPF)', 'timeFrame': 'up to Day 20', 'description': 'Estimated by aminohippurate sodium (PAH) clearance'}], 'secondaryOutcomes': [{'measure': 'Glomerular Filtration Rate (GFR)', 'timeFrame': 'Pre-dose (Day -4), Day 10, Day 20', 'description': 'Estimated by sinistrin clearance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tacrolimus', 'Advagraf®', 'Prograf®', 'Glomerular Filtration Rate', 'Effective Renal Plasma Flow', 'Pharmacokinetics', 'Pharmacodynamics'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25160518', 'type': 'DERIVED', 'citation': 'Zaltzman JS, Lai V, Schulz MZ, Moon KH, Cherney DZ. A randomized cross-over comparison of short-term exposure of once-daily extended release tacrolimus and twice-daily tacrolimus on renal function in healthy volunteers. Transpl Int. 2014 Dec;27(12):1294-302. doi: 10.1111/tri.12435. Epub 2014 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.', 'detailedDescription': 'This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian\n* No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder\n* Normal 12-lead Electrocardiogram (ECG)\n* Systolic blood pressure \\<140 mm Hg and diastolic blood pressure \\<90 mm Hg\n* Non-smoker within 3 months prior to screening\n* Willing to abstain from alcohol during the study\n\nExclusion Criteria:\n\n* Positive screen for illicit drug or alcohol consumption\n* Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)\n* Positive tuberculin skin test or known history of tuberculosis infection\n* Known history of serious head injuries, seizures or eating disorders\n* Body Mass Index \\<18.0 or \\>30.0\n* History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \\<130 g/L\n* Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.\n* Drug or alcohol abuse within 1 year prior to study entry\n* Steroid injections within 12 weeks prior to first dose of study drug\n* Live vaccine within 7 days prior to first dose of study drug'}, 'identificationModule': {'nctId': 'NCT01681134', 'briefTitle': 'A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'FKC-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advagraf followed by Prograf', 'interventionNames': ['Drug: Advagraf®', 'Drug: Prograf®']}, {'type': 'EXPERIMENTAL', 'label': 'Prograf followed by Advagraf', 'interventionNames': ['Drug: Advagraf®', 'Drug: Prograf®']}], 'interventions': [{'name': 'Advagraf®', 'type': 'DRUG', 'otherNames': ['tacrolimus XL, FK506E'], 'description': 'oral', 'armGroupLabels': ['Advagraf followed by Prograf', 'Prograf followed by Advagraf']}, {'name': 'Prograf®', 'type': 'DRUG', 'otherNames': ['tacrolimus, FK506'], 'description': 'oral', 'armGroupLabels': ['Advagraf followed by Prograf', 'Prograf followed by Advagraf']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5V 2T3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'INC Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Associate Director, Medical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Canada, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Canada, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}