Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00291603
Status:
COMPLETED
Last Update Posted:
2007-04-25
First Post:
2006-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Term Effects of FX Dialysers on QOL and 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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-24', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2007-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KD-QOL'}, {'measure': 'Feeling Thermometer'}], 'secondaryOutcomes': [{'measure': 'IL-6'}, {'measure': 'TNF-alpha'}, {'measure': 'hs-CRP'}, {'measure': 'white cell count'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dialysis', 'Renal Dialysis', 'inflammation', 'quality of life', 'End Stage Kidney Failure'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.\n\nThe dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.\n\nThese features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.\n\nAims:\n\n1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients\n2. To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.', 'detailedDescription': 'Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study.\n\nInclusion criteria -\n\n1. Age \\>18years\n2. Able to provide informed consent\n3. On haemodialysis for 3 months\n\nExclusion criteria -\n\n1. Active inflammatory, infective or neoplastic process within the last 1 month\n2. Active major psychiatric condition\n3. Currently on haemodiafiltration as haemodialysis modality\n\nDesign This study will involve an unblinded, cross-over design, with patients being randomised upon entry into one of 2 groups. The 2 groups will be - 1. HF80 dialyser (this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial); and 2. FX dialyser. Patients will have baseline tests performed prior to intervention and then repeated after 3 months. At 3 months, patients will then cross-over into the other group and tests repeated after a further 6 months.\n\nDue to the nature of the intervention, blinding will not be practical. The cross-over design will allow maximum power for this fixed and relatively small dialysis population (\\~50 patients).\n\nIndependent variables -\n\n1. Dialysis prescription on enrolment\n\n a. Including dialyser type (biocompatibility)\n2. Adequacy of dialysis\n\n 1. Urea reduction ratio\n 2. Kt/V\n3. Anaemia\n\n 1. Including iron studies\n 2. Including erythropoietin usage\n4. Calcium phosphate balance\n\n a. Including Parathyroid hormone levels\n5. Serum albumin\n\nOutcome markers -\n\n1. Quality of Life (i) KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients, that will be readily comparable to other studies.\n\n (ii) Feeling thermometer\n2. Inflammatory markers (i) High sensitivity c-reactive protein (ii) IL-6 (iii) White cell count.\n\nStatistical analysis:\n\nQuality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated. Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables. STATA 8.2 will be used to assist with the analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18years\n2. Able to provide informed consent\n3. On haemodialysis for 3 months\n\nExclusion Criteria:\n\n1. Active inflammatory, infective or neoplastic process within the last 1 month\n2. Active major psychiatric condition\n3. Currently on haemodiafiltration as haemodialysis modality'}, 'identificationModule': {'nctId': 'NCT00291603', 'briefTitle': 'Short Term Effects of FX Dialysers on QOL and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Sir Charles Gairdner Hospital'}, 'officialTitle': 'Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients', 'orgStudyIdInfo': {'id': '2005-192'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FX-class of dialyser', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6050', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Joondalup Health Campus Satellite Dialysis Unit', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Neil C Boudville, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Charles Gairdner Hospital', 'class': 'OTHER'}}}}