Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03104166
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Vascular Calcification in Chronic Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months', 'timeFrame': 'Six months', 'description': 'Serum samples will be drawn at the beginning of the trial and after six months treatment with either High-Flux or Medium Cut-Off filters. Vascular smooth muscle cells will be incubated with thee serum samples and calcification will be assessed with Alkaline Phosphatase/ WST8'}], 'secondaryOutcomes': [{'measure': 'Aortic Pulse wave velocity', 'timeFrame': 'Six months', 'description': 'Aortic Pulse wave velocity will be determined using the Vicorder Device.'}, {'measure': 'Calcification propensity', 'timeFrame': 'Six months', 'description': 'Calcification propensity will be determined as described earlier. (PMID: 24179171)'}, {'measure': 'Physical activity level', 'timeFrame': 'Six months', 'description': 'Physical activity level will be monitored for one week before and after treatment using an activity tracker.'}, {'measure': 'Cell culture: Incubation of VSMC with serum samples and assessment of • Alizarin staining/WST-8 • Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants • Apoptosis', 'timeFrame': 'Six months', 'description': 'Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Calcification']}, 'descriptionModule': {'briefSummary': '50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment.\n\nSerum samples will be drawn at baseline, after 4, 8 and 24 weeks.\n\nLater, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.\n\nPrimary endpoint:\n\nIn vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months\n\nCalcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.\n\nSecondary Endpoints:\n\nAortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months\n\nCell culture: Incubation of VSMC with serum samples obtained after 6 months\n\n* Alizarin staining/WST-8\n* Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants\n* Apoptosis\n\nThe treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years an older\n* Chronic dialysis patients for at least 3 months\n\nExclusion Criteria:\n\n* Serum albumin \\<32g/L at the last routine albumin measurement\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03104166', 'acronym': 'ModuVas', 'briefTitle': 'Modulation of Vascular Calcification in Chronic Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Modulation of Vascular Calcification in Chronic Dialysis Patients', 'orgStudyIdInfo': {'id': 'ModuVas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCO', 'description': 'Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.', 'interventionNames': ['Device: Medium Cut-Off (MCO) dialysis membrane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-Flux', 'description': 'Patients will be treated thrice weekly with High-Flux Dialysis membranes.', 'interventionNames': ['Device: High-Flux dialysis membrane']}], 'interventions': [{'name': 'Medium Cut-Off (MCO) dialysis membrane', 'type': 'DEVICE', 'description': 'Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.', 'armGroupLabels': ['MCO']}, {'name': 'High-Flux dialysis membrane', 'type': 'DEVICE', 'description': 'Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.', 'armGroupLabels': ['High-Flux']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Virchow', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Daniel Zickler', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}