Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT03618368
Status:
UNKNOWN
Last Update Posted:
2020-11-06
First Post:
2018-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'blinded group: as dialyzers are almost identical except for their labels, blinding is achieved by masking dialyzer labels.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1 blinded group on THERANOVA-500 dialyzer (Expanded Hemodialysis (HDx))\n\n1 blinded group on REVACLEAR-400 dialyzer (conventional hemodialysis (HD))\n\n1 non-blinded group on THERANOVA-500 dialyzer (Expanded Hemodialysis (HDx))\n\n1 non-blinded group on REVACLEAR-400 dialyzer (conventional hemodialysis (HD))'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-dialysis recovery time (intervention period)', 'timeFrame': 'through 6-week intervention period', 'description': 'All subjects are asked weekly on their mid-week session how long did it take them to recover from their previous hemodialysis session for the entire duration of the project (10 weeks). Mean post-dialysis recovery time report (in hours) of all subjects on THERANOVA-500 (5 reports/subject) compared to mean of all subjects on REVACLEAR-400 reports during the 6-week intervention period (5 reports/subject) is the primary outcome measure.(intended statistical test: 2-sample t-Test)(re continuous data, n=35/group)'}], 'secondaryOutcomes': [{'measure': 'Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400)', 'timeFrame': 'through 10-week study', 'description': 'This outcome refers to the mean post-hemodialysis recovery time reports (in hours) during 6-week intervention period (5 reports/subject) minus mean post-hemodialysis recovery time reports of 2-week pre and 2-week post intervention period (5 reports/subject)(all subjects)(intended statistical test: paired t-Test)(re continuous data, n=35/group)'}, {'measure': 'Post-hemodialysis recovery time difference (THERANOVA-500)', 'timeFrame': 'through 6-week intervention period', 'description': 'This outcome refers to the mean difference between blinded and non-blinded THERANOVA-500 treated subjects of post-hemodialysis recovery time (in hours) during the 6-week intervention period (5 reports/subject)(intended statistical test: Wilcoxon Rank Sum Test)(re continuous data, n \\<= 25/group). This outcome is to assess extent of placebo effect.'}, {'measure': 'Post-hemodialysis recovery time difference (REVACLEAR-400)', 'timeFrame': 'through 6-week intervention period', 'description': 'This outcome refers to the mean difference between blinded and non-blinded REVACLEAR-400 treated subjects of post-hemodialysis recovery time (in hours) during the 6-week intervention period (5 reports/subject)(intended statistical test: Wilcoxon Rank Sum Test)(re continuous data, n \\<= 25/group). This outcome is to assess extent of placebo effect.'}, {'measure': 'Post-hemodialysis recovery time difference mean gap (THERANOVA-500 vs REVACLEAR-400)', 'timeFrame': 'through 6-week intervention period', 'description': 'This outcome refers to comparison between mean difference of secondary outcome 3 and mean of secondary outcome 4 of post-hemodialysis recovery time (in hours)(intented statistical test: 2-sample t-Test)(re mean of means). This outcome is to assess extent of differential placebo effects between the intervention groups.'}, {'measure': 'Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400)', 'timeFrame': 'through 6-week intervention period', 'description': 'This outcome refers to the mean difference of percentage of subjects reporting no (zero) recovery time after treatment with THERANOVA-500 compared to mean percentage of subjects reporting no (zero) recovery time after treatment with REVACLEAR-400 during the 6-week intervention period (all subjects)(intended statistical test: 2-sample t-TEST (re continuous data, n = 35/group)'}, {'measure': 'Pre and post 6-week intervention period pre-dialysis levels of beta-2 microglobulin', 'timeFrame': '6 weeks', 'description': 'This outcome refers to the mean difference between pre-dialysis levels of beta-2 microglobulin (in nmol/L) (assay: immunoturbidimetry) pre-intervention period compared to post 6-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group)'}, {'measure': 'Pre and post 6-week intervention period pre-dialysis levels of procalcitonin', 'timeFrame': '6 weeks', 'description': 'This outcome refers to the mean difference between pre-dialysis levels of procalcitonin (in ng/ml) (assay: ELFA (Enzyme-Linked Fluorescent Assay) pre-intervention period compared to post 6-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group)'}, {'measure': 'Pre and post 6-week intervention period pre-dialysis levels of free light chains', 'timeFrame': '6 weeks', 'description': 'This outcome refers to the mean difference between pre-dialysis levels of free light chains (gamma and lambda) (in mg/L) (assay: immunoturbidimetry) pre-intervention period compared to post 6-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group)'}, {'measure': 'Pre and post 6-week intervention period pre-dialysis levels of interleukine-6', 'timeFrame': '6 weeks', 'description': 'This outcome refers to the mean difference between pre-dialysis levels of interleukine-6 (in pg/ml) (assay: ELISA) pre-intervention period compared to post 6-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group)'}, {'measure': 'Pre and post 6-week intervention period pre-dialysis levels of C reactive protein', 'timeFrame': '6 weeks', 'description': 'This outcome refers to the mean difference between pre-dialysis levels of C reactive protein (in mg/L) (assay: Heterogeneous enzyme immunoassay) pre-intervention period compared to post 6-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group)'}, {'measure': 'Quality of life (QoL) change (pre and at 2 weeks of intervention period)(adapted KDQoL-SF)', 'timeFrame': '2 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by adapted KDQoL-SF questionnaire (max score 130, higher better) pre-intervention period compared to post 2-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a locally validated adapted version of KDQoL-SF, Version 1.3, Copyright, RAND 1995,1996,1997, available in English and French.'}, {'measure': 'Quality of life (QoL) change (pre and at 4 weeks of intervention period)(adapted KDQoL-SF)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by adapted KDQoL-SF questionnaire (max score 130, higher better) pre-intervention period compared to post 4-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a locally validated adapted version of KDQoL-SF, Version 1.3, Copyright, RAND 1995,1996,1997, available in English and French.'}, {'measure': 'Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(adapted KDQoL-SF)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by adapted KDQoL-SF questionnaire (max score 130, higher better) at 4-week intervention period and week 8 of study between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a locally validated adapted version of KDQoL-SF, Version 1.3, Copyright, RAND 1995,1996,1997, available in English and French.'}, {'measure': 'Quality of life (QoL) change (pre and at 2 weeks of intervention period)(EQ-5D)', 'timeFrame': '2 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by EQ-5D questionnaire (max score 125, higher better) pre-intervention period compared to post 2-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a common validated instrument by EuroQol group available in multiple languages used here in its English and French Canadian versions.'}, {'measure': 'Quality of life (QoL) change (pre and at 4 weeks of intervention period)(EQ-5D)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by EQ-5D questionnaire (max score 125, higher better) pre-intervention period compared to post 4-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a common validated instrument by EuroQol group available in multiple languages used here in its English and French Canadian versions.'}, {'measure': 'Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(EQ-5D)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by EQ-5D questionnaire (max score 125, higher better) at 4-week intervention period and week 8 of study between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is a common validated instrument by EuroQol group available in multiple languages used here in its English and French Canadian versions.'}, {'measure': 'Quality of life (QoL) change (pre and at 2 weeks of intervention period)(rESAS)', 'timeFrame': '2 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by rESAS questionnaire (max score 100, higher better) pre-intervention period compared to post 2-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is the revised Edmonton Symptom Assessment System instrument available in English and in French.'}, {'measure': 'Quality of life (QoL) change (pre and at 4 weeks of intervention period)(rESAS)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by rESAS questionnaire (max score 100, higher better) pre-intervention period compared to post 4-week intervention period between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is the revised Edmonton Symptom Assessment System instrument available in English and in French.'}, {'measure': 'Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(rESAS)', 'timeFrame': '4 weeks', 'description': 'This outcome refers to the mean difference between QoL assessed by rESAS questionnaire (max score 100, higher better) at 4-week intervention period and week 8 of study between all subjects treated with THERANOVA-500 and all subjects treated with REVACLEAR-400 (intended statistical test: paired t-Test (re continuous data, n = 35/group). This questionnaire is the revised Edmonton Symptom Assessment System instrument available in English and in French.'}, {'measure': "Subjects's QoL questionnaire fill preference", 'timeFrame': 'at week 10 of study', 'description': 'At the end of the study (week 10) all subjects will be asked which QoL questionnaire (between the adapted KDQoL-SF, EQ-5D and rESAS) they prefer to fill for future routine use in the hemodialysis unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease on Dialysis']}, 'descriptionModule': {'briefSummary': 'Single blinded randomized controlled trial comparing Expanded Hemodialysis (HDx) using THERANOVA-500 dialyzer versus conventional hemodialysis (HD) using REVACLEAR-400 dialyzer in chronic hemodialysis patients over a 6-week intervention period. Primary endpoint is post-hemodialysis recovery time. Secondary endpoints are six pre-dialysis biomarker levels (b2-microglobuline, procalcitonine, free light chains (gamma-lambda), IL-6, CRP) and three Quality of Life (QoL)(adapted KDQoL-SF questionnaire, EQ-5D, and rESAS).', 'detailedDescription': "This is a randomized controlled trial involving 70 subjects divided in 4 groups: 25 single blinded subjects using THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) ; 25 single blinded subjects using REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD); 10 non-blinded subjects using THERANOVA-500 enabling Expanded Hemodialysis (HDx) and 10 non-blinded subjects using REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD) for their chronic hemodialysis treatments over an active intervention period of 6 weeks. All subjects are to be dialyzed using REVACLEAR-400 enabling conventional hemodialysis (HD) for two weeks prior and for two weeks after the intervention period.\n\nPrimary endpoint is mean post-hemodialysis recovery time (as reported by subjects once weekly) between groups (THERANOVA-500 vs REVACLEAR-400) (all subjects) during the 6-week intervention period.\n\nSecondary endpoints are:\n\n1. Post-hemodialysis recovery time change (mean of 2-week pre and 2-week post intervention period compared to mean during 6-week intervention period)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects),\n2. Post-hemodialysis recovery time difference (mean between blinded and non-blinded THERANOVA-500 treated subjects during the 6-week intervention period,\n3. Post-hemodialysis recovery time difference (mean between blinded and non-blinded REVACLEAR-400 treated subjects during the 6-week intervention period),\n4. Post-hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3,\n5. Percentage of subjects who report no (zero) recovery time (mean THERANOVA-500 vs mean REVACLEAR-400) during 6-week intervention period (all subjects),\n6. Pre and post 6-week intervention period pre-dialysis difference levels of beta-2 microglobulin (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(in nmol/L),\n7. Pre and post 6-week intervention period pre-dialysis difference levels of procalcitonin (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(in ng/ml),\n8. Pre and post 6-week intervention period pre-dialysis difference levels of free light chains (gamma and lambda)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(in mg/L),\n9. Pre and post 6-week intervention period pre-dialysis difference levels of interleukine-6 (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(in pg/ml),\n10. Pre and post 6-week intervention period pre-dialysis difference levels of C reactive protein (CRP)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(in mg/L),\n11. Quality of life change (pre and at 2 weeks of intervention period) (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by adapted KDQoL-SF questionnaire)(max score 130),\n12. Quality of life change (pre and at 4 weeks of intervention period) (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects) assessed by adapted KDQoL-SF questionnaire)(max score 130),\n13. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects) assessed by adapted KDQoL-SF (max score 130),\n14. Quality of life change (pre and at 2 weeks of intervention period)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by EQ-5D questionnaire)(max score 125),\n15. Quality of life change (pre and at 4 weeks of intervention period)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by EQ-5D questionnaire)(max score 125),\n16. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by EQ-5D questionnaire (max score 125),\n17. Quality of life change (pre and at 2 weeks of intervention period (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by rESAS)(max score 100),\n18. Quality of life change (pre and at 4 weeks of intervention period (mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by rESAS)(max score 100),\n19. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA-500 vs mean REVACLEAR-400)(all subjects)(assessed by rESAS)(max score 100),\n20. Subjects's QoL questionnaire fill preference (adapted KD QoL-SF vs EQ-5D vs rESAS) at study week 8."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age greater than 18 years, all genders.\n* HD at DrGLDUHC for more than 3 months, 3 times/week schedule, and using REVACLEAR-400.\n* Good vascular access (blood flow (Qb) \\> 300 during entire previous 6 HD sessions, no per-HD alteplase treatments used over the last 2 weeks, routine alteplase-lock allowed)\n* Signed informed consent\n* Likely to be able to participate for the duration of the clinical evaluation (no trips, no elective procedures, no transfer to another dialysis modality or HD facility, etc).\n* Able to fill questionnaires, staff assistance allowed.\n\nExclusion Criteria:\n\n* HD more than 3 times/week\n* HD on other dialyzers than REVACLEAR-400\n* Poor vascular access (from staff and Nephrologists' evaluation)\n* No consent or unable to answer questionnaires even with staff assistance."}, 'identificationModule': {'nctId': 'NCT03618368', 'briefTitle': 'Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)', 'organization': {'class': 'OTHER', 'fullName': 'Réseau de Santé Vitalité Health Network'}, 'officialTitle': 'Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)', 'orgStudyIdInfo': {'id': 'NEP2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blinded THERANOVA-500 dialyzer', 'description': 'This group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy.', 'interventionNames': ['Device: THERANOVA-500 dialyzer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Blinded REVACLEAR-400 dialyzer', 'description': 'This group of 25 subjects is dialyzed with masked REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD).', 'interventionNames': ['Device: REVACLEAR-400 dialyzer']}, {'type': 'EXPERIMENTAL', 'label': 'Unblinded THERANOVA-500 dialyzer', 'description': 'This group of 10 subjects is dialyzed with unmasked THERANOVA-500 dialyzer which enables Expanded Hemodialysis (HDx) therapy.', 'interventionNames': ['Device: THERANOVA-500 dialyzer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Unblinded REVACLEAR-400 dialyzer', 'description': 'This group of 10 subjects is dialyzed with unmasked REVACLEAR-400 dialyzer which enables conventional hemodialysis (HD).', 'interventionNames': ['Device: REVACLEAR-400 dialyzer']}], 'interventions': [{'name': 'THERANOVA-500 dialyzer', 'type': 'DEVICE', 'description': 'THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.', 'armGroupLabels': ['Blinded THERANOVA-500 dialyzer', 'Unblinded THERANOVA-500 dialyzer']}, {'name': 'REVACLEAR-400 dialyzer', 'type': 'DEVICE', 'description': 'REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).', 'armGroupLabels': ['Blinded REVACLEAR-400 dialyzer', 'Unblinded REVACLEAR-400 dialyzer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1C 2Z3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Dr Georges-L.-Dumont University Hospital Centre', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}], 'overallOfficials': [{'name': 'Marc Dorval, MD,MPH,MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr Georges-L.-Dumont University Hospital Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is no plan to share individual participant data as this was not approved by local ethic review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Réseau de Santé Vitalité Health Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}