Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-29 @ 7:49 AM
Study NCT ID:
NCT01722695
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Comparison of Revaclear With Larger Dialyzer
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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood count', 'timeFrame': '2 weeks (start and end of 6 consecutive dialysis sessions)', 'description': 'Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L).'}], 'primaryOutcomes': [{'measure': 'Dialysis dose Kt/V urea', 'timeFrame': '2 weeks (6 consecutive dialysis sessions)', 'description': 'Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.'}], 'secondaryOutcomes': [{'measure': 'Reduction rate of urea, creatinine, phosphate and ß2-microglobulin', 'timeFrame': '2 weeks (6 consecutive dialysis sessions)', 'description': 'Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).'}, {'measure': 'Total removal of creatinine, phosphate and ß2-microglobulin', 'timeFrame': '2 weeks (6 consecutive dialysis sessions)', 'description': 'Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.'}, {'measure': 'Albumin loss', 'timeFrame': '2 weeks (6 consecutive dialysis sessions)', 'description': 'Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Failure Chronic Requiring Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area.\n\nStudy design: open, randomized, cross-over, multicentric, controlled prospective\n\nMedical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs\n\nPatients/sample size: 30 adult chronic hemodialysis patients\n\nTreatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.\n\nObjectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss\n\nPrimary variable: dialysis dose Kt/V urea\n\nSecondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin\n\nSafety variable: albumin loss, blood count'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months\n* patients aged 18 years or more\n* written consent to participate in the study (informed consent)\n* dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min\n\nExclusion Criteria:\n\n* single-needle dialysis\n* pregnant and lactating women\n* participation in other interventional studies less than 3 months prior to study start\n* non-compliance with the dialysis prescription\n* hematocrit less than 28%\n* hospitalization\n* antibiotic therapy\n* active infection\n* active cancer\n* known positive serology for HIV, hepatitis B or C\n* serious hemostasis disorders\n* any comorbidity possibly conflicting with the study purpose or procedures'}, 'identificationModule': {'nctId': 'NCT01722695', 'acronym': 'Revacom HD', 'briefTitle': 'Performance Comparison of Revaclear With Larger Dialyzer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers', 'orgStudyIdInfo': {'id': '1499'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Revaclear followed by FX', 'interventionNames': ['Other: Dialyzer comparison']}, {'type': 'OTHER', 'label': 'FX followed by Revaclear', 'interventionNames': ['Other: Dialyzer comparison']}], 'interventions': [{'name': 'Dialyzer comparison', 'type': 'OTHER', 'description': 'Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).\n\nThe order of dialyzers used will be randomly assigned to the patient at randomization.', 'armGroupLabels': ['FX followed by Revaclear', 'Revaclear followed by FX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Dialyseinstitut Prim. Dr. W. Gießauf GmbH', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Alexander Rosenkranz, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Graz, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gambro Dialysatoren GmbH', 'class': 'INDUSTRY'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}