Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT03416192
Status:
WITHDRAWN
Last Update Posted:
2020-04-15
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D014511', 'term': 'Uremia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Capacity shortage', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.', 'timeFrame': '8 weeks'}, {'measure': 'Comparison of number of adverse effects during the study period.', 'timeFrame': '12 weeks'}, {'measure': 'Comparison of mean nPCR after 12 weeks.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dialysis', 'MCO', 'Middle molecules'], 'conditions': ['Chronic Kidney Diseases', 'Uremia']}, 'descriptionModule': {'briefSummary': 'The medium cut-off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.\n\nThe aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ongoing HDF treatment (\\>3 months)\n* Oliguric\n* Albumin ≥ 30\n* CRP \\<15\n* No acute myocardial infarction within 3 months.\n* Swedish or english speaking.\n\nExclusion Criteria:\n\n\\- Not able to understand the study information.'}, 'identificationModule': {'nctId': 'NCT03416192', 'briefTitle': '12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': '12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.', 'orgStudyIdInfo': {'id': '2017/830/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCO-HD', 'description': 'Hemodialysis with Medium Cut-Off filter', 'interventionNames': ['Device: MCO-HD', 'Device: high-flux HDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-flux HDF', 'description': 'Hemodiafiltration with standard high-flux filter', 'interventionNames': ['Device: MCO-HD', 'Device: high-flux HDF']}], 'interventions': [{'name': 'MCO-HD', 'type': 'DEVICE', 'description': 'Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.', 'armGroupLabels': ['High-flux HDF', 'MCO-HD']}, {'name': 'high-flux HDF', 'type': 'DEVICE', 'description': 'Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter', 'armGroupLabels': ['High-flux HDF', 'MCO-HD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anders Christensson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skane, Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}