Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-26 @ 2:37 PM
Study NCT ID:
NCT01726868
Status:
UNKNOWN
Last Update Posted:
2016-07-04
First Post:
2012-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017700', 'term': 'Embolism, Cholesterol'}], 'ancestors': [{'id': 'D004620', 'term': 'Embolism, Fat'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2012-11-10', 'studyFirstSubmitQcDate': '2012-11-11', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic hemodialysis', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Dose of drugs', 'timeFrame': 'Six months'}, {'measure': 'Incidence of lower limb amputation', 'timeFrame': 'Six months'}, {'measure': 'Incidence of gangrene', 'timeFrame': 'Six months'}, {'measure': 'Incidence of multi organ failure', 'timeFrame': 'Six months'}, {'measure': 'Survival rate', 'timeFrame': 'Six months'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cholesterol Embolism']}, 'referencesModule': {'references': [{'pmid': '34216189', 'type': 'DERIVED', 'citation': 'Ishiyama K, Sato T. Efficacy of LDL apheresis for the treatment of cholesterol crystal embolism: A prospective, controlled study. Ther Apher Dial. 2022 Apr;26(2):456-464. doi: 10.1111/1744-9987.13706. Epub 2021 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who meet all of the following criteria.\n\n* Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.\n* Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.\n\n 1. Patients with progressive renal dysfunction in the course of weeks or months.\n 2. Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.\n 3. Eosinophil count is more than 400 per microliter.\n* Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded.\n\n* Patients with contraindication to anticoagulant (Nafamostat Mesilate).\n* Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.\n* Patients with body weight less than 40kg.\n* Patients with a history of allergic reaction or hypersensitivity to blood purification.\n* Patients who cannot stop taking ACE inhibitors.\n* Patients with any disease in which corticosteroid, statin are contraindicated.\n* Patients participated in another clinical trial or study at the time of obtaining informed consent.\n* Patients receiving chronic hemodialysis.\n* Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT01726868', 'briefTitle': 'Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Japan Community Health Care Organization Sendai Hospital'}, 'officialTitle': 'Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism', 'orgStudyIdInfo': {'id': 'CCE-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposorber LA-15 System', 'interventionNames': ['Device: Liposorber LA-15 System']}], 'interventions': [{'name': 'Liposorber LA-15 System', 'type': 'DEVICE', 'description': 'Six sessions of blood purification treatment with Liposorber LA-15 System.', 'armGroupLabels': ['Liposorber LA-15 System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '981-8501', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Toshinobu Sato, MD, PhD', 'role': 'CONTACT', 'phone': '+81-22-275-3111'}], 'facility': 'Sendai Shakaihoken Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}], 'centralContacts': [{'name': 'Toshinobu Sato, MD, PhD', 'role': 'CONTACT', 'phone': '+81-22-275-3111'}], 'overallOfficials': [{'name': 'Toshinobu Sato, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Japan Community Health Care Organization Sendai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Community Health Care Organization Sendai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'TOSHINOBU SATO', 'investigatorAffiliation': 'Japan Community Health Care Organization Sendai Hospital'}}}}