Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04006093
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2019-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Apixaban in Subjects With Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-15', 'releaseDate': '2023-09-04'}], 'estimatedResultsFirstSubmitDate': '2023-09-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apixaban area Under the curve', 'timeFrame': 'Day 3', 'description': 'Measurement of apixaban plasma concentrations at different times.'}, {'measure': 'Apixaban maximum plasma concentration', 'timeFrame': 'Day 3', 'description': 'Measurement of apixaban plasma concentrations at different times.'}], 'secondaryOutcomes': [{'measure': 'anti-Xa activity', 'timeFrame': 'Hour 0, Hour 3, Hour 9 and Hour 72', 'description': 'anti-Xa activity plasma measurements'}, {'measure': 'TP activity', 'timeFrame': 'Hour 0, Hour 3, Hour 9 and Hour 72', 'description': 'TP activity plasma measurements'}, {'measure': 'TCA activity', 'timeFrame': 'Hour 0, Hour 3, Hour 9 and Hour 72', 'description': 'TCA activity plasma measurements'}, {'measure': 'Apixaban urinary elimination', 'timeFrame': 'Day 3', 'description': 'Measurement of apixaban urinary concentrations'}, {'measure': 'Apixaban maximum peritoneal concentration', 'timeFrame': 'day 3', 'description': 'Measurement of apixaban peritoneal fluid concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Renal Insufficiency', 'Peritoneal Dialysis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.', 'detailedDescription': 'Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant with 21\\<BMI\\<40\n* French participant\n* Participant able to consent\n* Participant with social insurance\n* Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated\n\nExclusion Criteria:\n\n* Participant with hypersensibility reactions to apixaban\n* Participant with a history of major bleeding\n* Participant already on anticoagulant\n* Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage \\> 300 mg\n* Participant on potent inhibitors of CYP 3A4 and P-gp\n* Participant on inducers of CYP3A4 and P-sp\n* Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment\n* Participant receiving or having received antibiotic treatment within 14 days prior to study\n* Pregnant or lactating women\n* Participant with known hypersensitivity reactions to icodextrin\n* Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)\n* Participant with "Normal renal function" with glomerular filtration rate \\< 90 ml/min'}, 'identificationModule': {'nctId': 'NCT04006093', 'acronym': 'ApiDP', 'briefTitle': 'Apixaban in Subjects With Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study', 'orgStudyIdInfo': {'id': '19-060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'participants with normal renal function', 'interventionNames': ['Drug: Apixaban Oral']}, {'type': 'EXPERIMENTAL', 'label': 'participants with end-stage renal disease', 'interventionNames': ['Drug: Apixaban Oral']}], 'interventions': [{'name': 'Apixaban Oral', 'type': 'DRUG', 'description': 'one Tablet 5mg', 'armGroupLabels': ['participants with end-stage renal disease', 'participants with normal renal function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-04', 'type': 'RELEASE'}, {'date': '2024-03-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital, Caen'}}}}