Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03510520
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'PARALLEL', 'interventionModelDescription': 'This is a single-centre, pilot, open-label, interventional, randomised controlled study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)', 'timeFrame': '6 months', 'description': 'Change in vascular endothelial marker score (derived from multiple biomarkers)'}], 'secondaryOutcomes': [{'measure': 'Change in pulse wave velocity', 'timeFrame': '6 months', 'description': 'Change in pulse wave velocity as measured by non-invasive pulse wave analysis device'}, {'measure': 'Change in pre-dialysis serum albumin', 'timeFrame': '3 & 6 months', 'description': 'Change in pre-dialysis serum albumin'}, {'measure': 'Change in pre-dialysis CRP', 'timeFrame': '3 & 6 months', 'description': 'Change in pre-dialysis CRP'}, {'measure': 'Change in components of pre-dialysis "middle molecule" panel', 'timeFrame': '3 & 6 months', 'description': 'Change in components of pre-dialysis "middle molecule" panel (this includes beta 2 microglobulin, serum free light chains, leptin, beta trace protein and prolactin)'}, {'measure': 'Change in components of cytokine panel', 'timeFrame': '3 & 6 months', 'description': 'Change in components of cytokine panel (including IL-6, TNFa, ICAM \\& VEGF)'}, {'measure': 'Change in numbers blood pressure medications', 'timeFrame': '6 months', 'description': 'Change in numbers blood pressure medications'}, {'measure': 'Change in number of phosphate binder medications', 'timeFrame': '6 months', 'description': 'Change in number of phosphate binder medications'}, {'measure': 'Change in Advanced Glycation End Products (AGE)', 'timeFrame': '6 months', 'description': 'Change in Advanced Glycation End Products (AGE)'}, {'measure': 'Change in inter-dialytic urine volume', 'timeFrame': '6 months', 'description': 'Change in inter-dialytic urine volume'}, {'measure': 'Change in IPOS-Renal (Integrated Palliative Care Outcome Score)', 'timeFrame': '3 & 6 months', 'description': 'Change in IPOS-Renal (Integrated Palliative Care Outcome Score)'}, {'measure': 'Change in self-sported dialysis recovery time', 'timeFrame': '3 & 6 months', 'description': 'Change in self-sported dialysis recovery time'}, {'measure': 'Change in Chalder fatigue scale', 'timeFrame': '3 & 6 months', 'description': 'Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)'}, {'measure': 'Hospitalisation episodes', 'timeFrame': '6 months', 'description': 'Number of hospitalisation episodes during 6 months study period'}, {'measure': 'All-cause mortality', 'timeFrame': '6 months', 'description': 'All-cause mortality'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '6 months', 'description': 'Cardiovascular mortality'}, {'measure': 'Change in augmentation pressure (AP)', 'timeFrame': '6 months', 'description': 'Change in segmentation pressure as measured by non-invasive pulse wave analysis device'}, {'measure': 'Change in heart-rate adjusted augmentation index (AI)', 'timeFrame': '6 months', 'description': 'Change in heart-rate adjusted augmentation index (AI) as measured by non-invasive pulse wave analysis device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Haemodialysis', 'Hemodiafiltration', 'Haemodiafiltration', 'Dialysis membrane', 'Endothelial Microvesicles', 'Pulse Wave Velocity'], 'conditions': ['End Stage Renal Disease', 'Cardiovascular Diseases', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate haemodialysis treatment using a medium cut-off dialysis membrane (Theranova) compared with on-line haemodiafiltration treatment with respect to markers of endothelial health (plasma endothelial microvesicle levels, pro-inflammatory and pro-coagulant markers).\n\nThis study will also compare the 2 treatment modalities with respect to several other outcome measures including patient-reported outcome measures, haemodynamic parameters and advanced glycation end-products.', 'detailedDescription': 'To date, methods of improving outcomes for haemodialysis patients have focused on improving small molecule clearance (urea); however, the benefits do not appear to be linear and increasing Kt/V above 1.3 shows no benefit. Current dialysis therapies are unable to provide effective clearance of larger "middle molecules" (between 20kDa and 60kDa) and retention of these molecules may be linked to poor outcomes in haemodialysis patients.\n\nMedium cut-off (MCO) dialysis membranes have been recently developed to address this area of unmet need and provide an enhanced clearance of some larger middle molecules when compared with high flux haemodialysis (HFHD) and even high volume haemodiafiltration (HDF). The clinical benefit of this therapy is yet to be defined.\n\nThe aim of this study is to investigate the effect of HDx therapy (expanded haemodialysis therapy through the use of a MCO haemodialysis membrane- Theranova) on vascular endothelial and inflammatory biomarkers compared with high volume HDF therapy. Through the use of endothelial microvesicles (EMV) as a marker of vascular endothelial health, which strongly correlate with cardiovascular outcomes in end-stage real disease (ESRD) patients, this pilot study will take the first steps into exploring whether HDx treatment provides clinical benefits in addition to its simplicity of implementation. Additionally, other important parameters, such as dialysis recovery time, patient-reported outcome measures and volume management will also be explored and compared with high volume HDF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week\n* Ability to consent\n\nExclusion Criteria:\n\n* Planned live donor renal transplant within 6 months (with confirmed date)\n* Planned switch in renal replacement modality (ie. to peritoneal dialysis or home haemodialysis)\n* Clinician predicted prognosis \\< 6 months'}, 'identificationModule': {'nctId': 'NCT03510520', 'acronym': 'MoDal', 'briefTitle': 'Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF', 'orgStudyIdInfo': {'id': 'R04863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medium Cut-Off Haemodialysis (Theranova)', 'description': 'Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).', 'interventionNames': ['Device: Medium Cut-Off Haemodialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-Line Haemodiafiltration', 'description': 'Participant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment).', 'interventionNames': ['Device: On-Line Haemodiafiltration']}], 'interventions': [{'name': 'Medium Cut-Off Haemodialysis', 'type': 'DEVICE', 'description': 'Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months', 'armGroupLabels': ['Medium Cut-Off Haemodialysis (Theranova)']}, {'name': 'On-Line Haemodiafiltration', 'type': 'DEVICE', 'description': 'Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)', 'armGroupLabels': ['On-Line Haemodiafiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Manchester NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sandip Mitra, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manchester University NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is yet to be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Manchester Metropolitan University', 'class': 'OTHER'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}