Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-26 @ 6:22 AM
Study NCT ID:
NCT06376968
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-dialysis body weight', 'timeFrame': '12 weeks', 'description': 'percentage of sessions with reached prescribed post-dialysis body weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Dialysis']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:\n\n• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.\n\nA crossover design is used to compare treatments with or without the BioLogic Fusion function activated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects ≥18 years of age\n* Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months\n* Dialysis frequency 3 x per week\n* Dialysis duration per session ≥ 4h\n* Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes\n* No residual renal function (definition: ≤100 ml urine/day) - changed to "No to minimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIP version 6)\n* Stable dry body weight for at least 4 weeks\n* Subjects who are willing to give a voluntary consent to participate in the study\n\nExclusion Criteria:\n\n* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)\n* Vascular access insufficiency (mean blood flow \\<200ml/min)\n* Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6)\n* Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)\n* Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period\n* Factors which may interfere with full participation in the trial\n* Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU)\n* Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study'}, 'identificationModule': {'nctId': 'NCT06376968', 'briefTitle': 'Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'B.Braun Avitum AG'}, 'officialTitle': 'Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis', 'orgStudyIdInfo': {'id': 'BA-G-H-1604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioLogic Fusion followed by standard dialysis', 'description': 'Patients will be dialysed first with the BioLogic Fusion feature activated and then switched to standard dialysis with the BioLogic Fusion feature de-activated', 'interventionNames': ['Device: BioLogic Fusion']}, {'type': 'EXPERIMENTAL', 'label': 'Standard dialysis followed by BioLogic Fusion', 'description': 'Patients will be dialysed first with standard dialysis with the BioLogic Fusion feature de-activated and then switched to the BioLogic Fusion feature activated', 'interventionNames': ['Device: BioLogic Fusion']}], 'interventions': [{'name': 'BioLogic Fusion', 'type': 'DEVICE', 'description': 'Dialysis conducted with Dialog iQ dialysis machine either using the BioLogic Fusion option or not using it. This is only a biologic feedback system using blood pressure and residual blood volume as parameters to predict potential hypotensive episodes. If switched off, standard dialysis treatment happens, if switched on, the system tries to predict and prevent hypotensive episodes.', 'armGroupLabels': ['BioLogic Fusion followed by standard dialysis', 'Standard dialysis followed by BioLogic Fusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Zucchelli, Prof.', 'role': 'CONTACT'}, {'name': 'Annalisa Zucchelli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Strube Frank', 'role': 'CONTACT', 'email': 'frank.strube@bbraun.com', 'phone': '+4915257240618'}, {'name': 'Seebode Christina, Dr.', 'role': 'CONTACT', 'email': 'christina.seebode@bbraun.com'}], 'overallOfficials': [{'name': 'Annalisa Zucchelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.Braun Avitum AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}