Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT03456232
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017583', 'term': 'Hemodiafiltration'}], 'ancestors': [{'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D006440', 'term': 'Hemofiltration'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-05', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of moderate molecule substance', 'timeFrame': '4 hours after dialysis', 'description': 'Clearance rate of b2-microglobulin for one dialysis.'}], 'secondaryOutcomes': [{'measure': 'Left ventricular ejection fraction', 'timeFrame': '4 hours after dialysis', 'description': 'Left ventricular ejection fraction is calculated by dividing the volume of blood pumped from the left ventricle per beat, also known as stroke volume, by the end-diastolic volume.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'hemodiafiltration', 'end-stage renal disease'], 'conditions': ['Chronic Kidney Failure']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.', 'detailedDescription': 'Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.\n\nHemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has end-stage renal disease.\n2. Subject has been on regular dialysis treatment for at least 6 months.\n3. Subject has autologous vascular access.\n4. Subject is offered thrice weekly hemodialysis.\n5. Subject is offered 4 hours duration hemodialysis.\n\nExclusion Criteria:\n\n1. Infectious disease\n2. Poor echocardiographic window that was unsuitable for interpretation'}, 'identificationModule': {'nctId': 'NCT03456232', 'briefTitle': 'High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease', 'orgStudyIdInfo': {'id': 'GDREC2017324H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-flux hemodialysis', 'description': 'High-flux hemodialysis lasting for 4 hours', 'interventionNames': ['Other: High-flux hemodialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodiafiltration', 'description': 'Hemodiafiltration lasting for 4 hours', 'interventionNames': ['Other: Hemodiafiltration']}], 'interventions': [{'name': 'High-flux hemodialysis', 'type': 'OTHER', 'description': 'High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.', 'armGroupLabels': ['High-flux hemodialysis']}, {'name': 'Hemodiafiltration', 'type': 'OTHER', 'description': 'Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.', 'armGroupLabels': ['Hemodiafiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei shi, MD,PhD', 'role': 'CONTACT', 'email': '13925056339@163.com', 'phone': '＋86-20-83850849'}, {'name': 'Yi Li, Master', 'role': 'CONTACT', 'email': '13580588265@139.com', 'phone': '＋86-20-81346722'}, {'name': 'Yi Li, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shuangxin Liu, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jianchao Ma, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lixia Xu, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuanhan Chen, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ting Lin, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yi Li, Master', 'role': 'CONTACT', 'email': '13580588265@139.com', 'phone': '＋86-20-81346722'}], 'overallOfficials': [{'name': 'Wei Shi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Supporting Information: study protocol, statistic analysis plan, informed consent form, clinical study report.\n\nTime Frame: Data will be available within 1 year of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review panel. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}