Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06671535
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D011537', 'term': 'Pruritus'}], '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'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-02', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5D Elman Itch Scale total score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.'}], 'secondaryOutcomes': [{'measure': 'WI-NRS score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '24-hour Worst Itching Intensity Numerical Rating Scale'}, {'measure': 'Skindex-16 score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Multidimensional tool to assess pruritis'}, {'measure': 'Itch-MOS score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.'}, {'measure': '5D Elman Itch Scale total score', 'timeFrame': 'From the end of active treatment to the end of follow-up (4 weeks)'}, {'measure': 'WI-NRS score', 'timeFrame': 'From the end of active treatment to the end of follow-up (4 weeks)'}, {'measure': 'Skindex-16 score', 'timeFrame': 'From the end of active treatment to the end of follow-up (4 weeks)'}, {'measure': 'Itch-MOS score', 'timeFrame': 'From the end of active treatment to the end of follow-up (4 weeks)'}, {'measure': 'C-reactive protein concentration', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks'}, {'measure': 'Serum ferritin', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polymethylmethacrylate membranes', 'CKD-associated pruritis', 'PMMA membranes'], 'conditions': ['CKD (Chronic Kidney Disease) Stage 5D', 'Hemodialysis', 'Pruritis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.\n\nThe main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?\n\nResearchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.\n\nParticipants will:\n\n* receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months;\n* fill in questionnaires about intensity of pruritis and its impact on daily life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;\n* Moderate-to-severe pruritis (WI-NRS score ≥ 4);\n* Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);\n* Dialysis treatment regimen: three sessions per week of at least 4 hours duration;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.\n* Noncompliance of the patient with the protocol (in the investigator's opinion).\n* Use of haemodiafiltration."}, 'identificationModule': {'nctId': 'NCT06671535', 'briefTitle': 'Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis', 'orgStudyIdInfo': {'id': 'PMMA and pruritis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMMA arm', 'description': 'Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months.', 'interventionNames': ['Device: Polymethylmethacrylate membrane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polysulfone arm', 'description': 'Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months.', 'interventionNames': ['Device: polysulfone membranes']}], 'interventions': [{'name': 'Polymethylmethacrylate membrane', 'type': 'DEVICE', 'description': 'A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.', 'armGroupLabels': ['PMMA arm']}, {'name': 'polysulfone membranes', 'type': 'DEVICE', 'description': 'Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.', 'armGroupLabels': ['Polysulfone arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '198103', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ekaterina PARSHINA, PhD', 'role': 'CONTACT', 'email': 'pannn@yandex.ru', 'phone': '89216577372'}, {'name': 'Alexey Tolkach, MD', 'role': 'CONTACT', 'email': 'ab2769@mail.ru'}], 'facility': 'Saint Petersburg State University Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Ekaterina Parshina, PhD', 'role': 'CONTACT', 'email': 'pannn@yandex.ru', 'phone': '+7(921)6577372'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Nephrology and Dialysis department', 'investigatorFullName': 'Ekaterina Parshina', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}