Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 8:46 AM
Study NCT ID:
NCT05771350
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2023-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-03-05', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dialytic removal of indoxyl sulpahte', 'timeFrame': 'one month when all samples were collected', 'description': 'assessed by the reduction ration of indoxyl sulphate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maintenance hemodialysis patients aged more than 18 years\n\nExclusion Criteria:\n\n* active illnesses, hospitalization, malignancy'}, 'identificationModule': {'nctId': 'NCT05771350', 'briefTitle': 'Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'FMASU MD 301/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'online hemodiafiltration', 'interventionNames': ['Procedure: online hemodiafiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high flux hemodialysis', 'interventionNames': ['Procedure: high flux hemodialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low flux hemodialysis', 'interventionNames': ['Procedure: low flux hemodialysis']}], 'interventions': [{'name': 'online hemodiafiltration', 'type': 'PROCEDURE', 'description': '20 patients on regular hemodialysis received online hemodiafiltration', 'armGroupLabels': ['online hemodiafiltration']}, {'name': 'high flux hemodialysis', 'type': 'PROCEDURE', 'description': '20 patients on regular hemodialysis received high flux hemodialysis', 'armGroupLabels': ['high flux hemodialysis']}, {'name': 'low flux hemodialysis', 'type': 'PROCEDURE', 'description': '20 patients on regular hemodialysis received low flux hemodialysis', 'armGroupLabels': ['low flux hemodialysis']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed sary gharib', 'investigatorAffiliation': 'Ain Shams University'}}}}