Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 8:53 AM
Study NCT ID:
NCT04160351
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis
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': 'CROSSOVER', 'interventionModelDescription': 'This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-09', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Removal of Beta-2-microglobulin', 'timeFrame': '4 weeks', 'description': 'Changes to Beta-2-microglobulin level'}, {'measure': 'Changes to Quality of Life', 'timeFrame': '27 weeks', 'description': 'Changes to Quality of life Using SF-36'}], 'secondaryOutcomes': [{'measure': 'Inflammatory state after intervention', 'timeFrame': '4 weeks', 'description': 'Changes to C-Reactive Protein Level'}, {'measure': 'Changes to Quality of Life', 'timeFrame': '27 weeks', 'description': 'Changes to Quality of life Using EQ-5D-5L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis-Associated Amyloidosis', 'Dialysis Amyloidosis', 'Quality of Life'], 'conditions': ['Hemodialysis-Associated Amyloidosis', 'Dialysis Amyloidosis', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.', 'detailedDescription': 'This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.\n\nPatients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or above\n2. End stage kidney failure receiving hemodialysis for at least 3 years\n3. Currently receiving hemodialysis at our center regularly\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with hemodiafiltration\n2. Catheter-related blood stream infection in the preceding 4 weeks\n3. Malfunctioning of HD catheter\n4. Planned transfer to peritoneal dialysis or transplant within 90 days\n5. Pregnancy\n6. History of active alcohol or substance abuse in the previous 6 months\n7. Concurrent participation in another interventional study\n8. Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes"}, 'identificationModule': {'nctId': 'NCT04160351', 'acronym': 'HD-1', 'briefTitle': 'A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Selayang Hospital'}, 'officialTitle': 'A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis', 'orgStudyIdInfo': {'id': 'HS/CTP/HD/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCO Dialyser', 'description': '12 treatments (4 weeks) with Medium Cut-Off Dialyzer', 'interventionNames': ['Device: Theranova 400']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Flux Dialyser', 'description': '12 treatments (4 weeks) with High Flux Dialyzer', 'interventionNames': ['Device: Elisio-19H']}], 'interventions': [{'name': 'Theranova 400', 'type': 'DEVICE', 'description': 'medium cut-off dialyser', 'armGroupLabels': ['MCO Dialyser']}, {'name': 'Elisio-19H', 'type': 'DEVICE', 'description': 'high flux dialyser', 'armGroupLabels': ['High Flux Dialyser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Batu Caves', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Selayang Hospital', 'geoPoint': {'lat': 3.238, 'lon': 101.682}}], 'overallOfficials': [{'name': 'Hin Seng Wong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ministry of Health, Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selayang Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}