Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00788905
Status:
UNKNOWN
Last Update Posted:
2013-03-29
First Post:
2008-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Conventional Dialysis and the Allient System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-21', 'releaseDate': '2013-12-04'}, {'resetDate': '2014-04-01', 'releaseDate': '2014-02-18'}, {'resetDate': '2017-05-17', 'releaseDate': '2017-04-10'}], 'estimatedResultsFirstSubmitDate': '2013-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2008-09-23', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of specific waste products from blood determined through subject blood and dialysate samples', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Inflammation as determined by levels of specific inflammatory markers', 'timeFrame': '3 weeks'}, {'measure': "Red blood cell lifespan determined through a measurement of CO in the subject's breath", 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis'], 'conditions': ['End Stage Renal Disease', 'Chronic Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '25710773', 'type': 'DERIVED', 'citation': 'Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maintenance in-center hemodialysis\n* Age greater than or equal to 18 years\n* Has been on hemodialysis for at least 4 months\n* Uses a standard single-pass dialysis machine with a high-flux dialyzer\n\nExclusion Criteria:\n\n* Hospitalization during the 8 weeks preceding enrollment\n* Infection requiring antibiotic treatment during the 8 weeks preceding enrollment\n* Central venous cather as dialysis access\n* Uncontrollable blood coagulation anomalies\n* Smokers\n* Dialysis regimen other than 3 times weekly\n* In ability to understand the English language and give informed consent for participation in the study'}, 'identificationModule': {'nctId': 'NCT00788905', 'briefTitle': 'Comparison of Conventional Dialysis and the Allient System', 'organization': {'class': 'OTHER', 'fullName': 'Renal Research Institute'}, 'officialTitle': 'Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System', 'orgStudyIdInfo': {'id': '065-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase).', 'interventionNames': ['Device: Allient System']}], 'interventions': [{'name': 'Allient System', 'type': 'DEVICE', 'description': 'The Allient System uses a different type of blood pump and a lower volume of dialysate.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Irving Place Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Upper Manhattan Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Yorkville Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nathan W. Levin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Research Institute'}, {'name': 'Peter Kotanko, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Renal Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renal Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renal Solutions, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-12-04', 'type': 'RELEASE'}, {'date': '2014-01-21', 'type': 'RESET'}, {'date': '2014-02-18', 'type': 'RELEASE'}, {'date': '2014-04-01', 'type': 'RESET'}, {'date': '2017-04-10', 'type': 'RELEASE'}, {'date': '2017-05-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Renal Research Institute'}}}}