Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT01043094
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
2009-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RMorgan@KowaUS.com', 'phone': '919-433-1600', 'title': 'Roger Morgan, MD, FACS', 'organization': 'Kowa Research Institute, Inc.'}, 'certainAgreement': {'otherDetails': 'PI not to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pitavastatin 4mg Renal Impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pitavastatin 4mg Healthy Subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'Medra'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitavastatin 4mg Renal Impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis'}, {'id': 'OG001', 'title': 'Pitavastatin 4mg Healthy Subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'spread': '39', 'groupId': 'OG000'}, {'value': '145', 'spread': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Area under the curve from start to elimination for Pitavastatin.', 'unitOfMeasure': 'nanogram hour per milliliter (ng•h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitavastatin 4mg Renal Impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis'}, {'id': 'OG001', 'title': 'Pitavastatin 4mg Healthy Subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pitavastatin 4mg Renal Impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis'}, {'id': 'FG001', 'title': 'Pitavastatin 4mg Healthy Subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pitavastatin 4mg Renal Impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis'}, {'id': 'BG001', 'title': 'Pitavastatin 4mg Healthy Subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '15.41', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '2.62', 'groupId': 'BG001'}, {'value': '53.1', 'spread': '10.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2009-12-18', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2010-01-04', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-05', 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))', 'timeFrame': '48 hours', 'description': 'Area under the curve from start to elimination for Pitavastatin.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': '3 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Renal Impairment']}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):\n\nThe 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.\n* Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis \\[if able to pass urine\\]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.\n* Subject provides written informed consent before any study-specific evaluation is performed.\n* Subject is able and willing to comply with the protocol and study procedures.\n\nExclusion Criteria:\n\n* Subject is on maintenance hemodialysis.\n* Subject has a BMI of \\>37 kg/m2.'}, 'identificationModule': {'nctId': 'NCT01043094', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'NK-104-4.01US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin 4mg renal impaired', 'description': 'Subjects with severe renal impairment (glomerular filtration rate \\[GFR\\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis', 'interventionNames': ['Drug: Pitavastatin 4mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pitavastatin 4mg healthy subjects', 'description': 'Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)', 'interventionNames': ['Drug: Pitavastatin 4mg']}], 'interventions': [{'name': 'Pitavastatin 4mg', 'type': 'DRUG', 'description': 'Pitavastatin 4mg single dose', 'armGroupLabels': ['Pitavastatin 4mg healthy subjects', 'Pitavastatin 4mg renal impaired']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Research Institute, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}