Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-04-14 @ 5:57 PM
Study NCT ID:
NCT01582893
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Permeability Enhancement to Reduce Chronic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of CD162 expression on monocytes', 'timeFrame': '8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)', 'description': 'change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)'}], 'secondaryOutcomes': [{'measure': 'Albumin blood level', 'timeFrame': '8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)', 'description': 'change of albumin blood level, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inflammation', 'dialysis'], 'conditions': ['End Stage Renal Disease', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dialysis treatment for ≥ 3 months\n* Dialysis 3x weekly\n* Vascular access by fistula or CVC providing QB of ≥ 250 ml/min\n* Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study\n* CRP \\> 5mg/L at least once within 12 weeks before inclusion\n* Age \\> 18 and \\< 99 Years\n* Ability to give written informed consent\n\nExclusion Criteria:\n\n* Missing informed consent form\n* Clinically manifested infection or current CRP-value \\> 50mg/L\n* Serum albumin \\< 35g/L\n* Intake of immune suppressive medication\n* Pregnancy or lactation\n* Participation in a different study'}, 'identificationModule': {'nctId': 'NCT01582893', 'acronym': 'PERCI', 'briefTitle': 'Permeability Enhancement to Reduce Chronic Inflammation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'Permeability Enhancement to Reduce Chronic Inflammation', 'orgStudyIdInfo': {'id': '1492'}, 'secondaryIdInfos': [{'id': 'CIV-11-10-002741', 'type': 'OTHER', 'domain': 'Eudamed'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCO1100-P14L', 'description': 'HCO1100 is connected in row with low flux dialyzer P14L', 'interventionNames': ['Device: HCO1100']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P210H', 'description': 'High flux Filter P210H', 'interventionNames': ['Device: P210H']}], 'interventions': [{'name': 'HCO1100', 'type': 'DEVICE', 'description': 'Dialysis', 'armGroupLabels': ['HCO1100-P14L']}, {'name': 'P210H', 'type': 'DEVICE', 'description': 'Dialysis', 'armGroupLabels': ['P210H']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'KfH Bachstzelzenweg 4', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '10625', 'city': 'Berlin', 'country': 'Germany', 'facility': 'KfH-Bismarkstrasse 95-96', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Matthias Girndt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Martin-Luther-Universität Halle-Wittenberg'}, {'name': 'Ralf Schindler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité, Humboldt Universität Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gambro Dialysatoren GmbH', 'class': 'INDUSTRY'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}