Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT00735059
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2008-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-20', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'protein-bound toxin removal', 'timeFrame': 'pre and post dialysis treatment'}, {'measure': 'low-molecular weight protein removal', 'timeFrame': 'pre and post dialysis treatment'}, {'measure': 'small solute removal', 'timeFrame': 'pre and post dialysis treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dialysis membrane', 'Polynephron', 'Elisio H', 'Polyethersulfone', 'Diapes', 'PES-DS', 'online post-dilution hemodiafiltration', 'hemodialysis', 'protein-bound toxins', 'beta-2-microglobulin', 'hemodialysis patients'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high \\[10\\]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months\n* Hematocrit \\>30 %\n* Routine anticoagulation and erythropoietin regimen\n* No vascular access related problems (A/V-fistula, graft or bi-flow catheter)\n* No ongoing infection\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Inclusion criteria not met\n* Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy\n* Unstable clinical condition (e.g. cardiac or vascular instability)\n* Life expectancy less than 12 months\n* Known coagulation problems\n* Patients participating in another study interfering with the planned study'}, 'identificationModule': {'nctId': 'NCT00735059', 'briefTitle': 'Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures', 'organization': {'class': 'OTHER', 'fullName': 'EXcorLab GmbH'}, 'officialTitle': 'Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures', 'orgStudyIdInfo': {'id': 'KSEL0702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'treatment with dialyzer ELISIO 170H', 'interventionNames': ['Device: treatment with the dialyzer ELISIO 170H']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'treatment with dialyzer PES-170DS', 'interventionNames': ['Device: treatment with the dialyzer PES-170DS']}], 'interventions': [{'name': 'treatment with the dialyzer ELISIO 170H', 'type': 'DEVICE', 'description': 'one week of three consecutive dialysis treatments, \\> 3 hours', 'armGroupLabels': ['1']}, {'name': 'treatment with the dialyzer PES-170DS', 'type': 'DEVICE', 'description': 'one week of three consecutive dialysis treatments, \\> 3 hours', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Raymond Vanholder, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ghent, Nephrology Section'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EXcorLab GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nipro Europe N.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Horst-Dieter Lemke, Biochemist, Chief Executive Officer', 'oldOrganization': 'EXcorLab GmbH'}}}}