Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)

Réseau de Santé Vitalité Health Network70 enrolled

Overview

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).

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. Primary 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. Secondary endpoints are: 1. 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), 2. Post-hemodialysis recovery time difference (mean between blinded and non-blinded THERANOVA-500 treated subjects during the 6-week intervention period, 3. Post-hemodialysis recovery time difference (mean between blinded and non-blinded REVACLEAR-400 treated subjects during the 6-week intervention period), 4. Post-hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3, 5. Percentage of subjects who report no (zero) recovery time (mean THERANOVA-500 vs mean REVACLEAR-400) during 6-week intervention period (all subjects), 6. 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), 7. 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), 8. 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), 9. 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), 10. 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), 11. 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), 12. 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), 13. 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), 14. 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), 15. 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), 16. 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), 17. 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), 18. 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), 19. 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), 20. Subjects's QoL questionnaire fill preference (adapted KD QoL-SF vs EQ-5D vs rESAS) at study week 8.

Conditions

End Stage Renal Disease on Dialysis

Interventions

THERANOVA-500 dialyzerDEVICE

THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.

REVACLEAR-400 dialyzerDEVICE

REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than 18 years, all genders. * HD at DrGLDUHC for more than 3 months, 3 times/week schedule, and using REVACLEAR-400. * 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) * Signed informed consent * 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). * Able to fill questionnaires, staff assistance allowed. Exclusion Criteria: * HD more than 3 times/week * HD on other dialyzers than REVACLEAR-400 * Poor vascular access (from staff and Nephrologists' evaluation) * No consent or unable to answer questionnaires even with staff assistance.

Locations (1)

Dr Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada

Outcomes

Primary Outcomes

Post-dialysis recovery time (intervention period)

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)

Time frame: through 6-week intervention period

Secondary Outcomes

Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400)

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)

Time frame: through 10-week study

Post-hemodialysis recovery time difference (THERANOVA-500)

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.

Time frame: through 6-week intervention period

Post-hemodialysis recovery time difference (REVACLEAR-400)

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.

Data from ClinicalTrials.gov

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Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Time frame: through 6-week intervention period

Post-hemodialysis recovery time difference mean gap (THERANOVA-500 vs REVACLEAR-400)

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.

Time frame: through 6-week intervention period

Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400)

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)

Time frame: through 6-week intervention period

Pre and post 6-week intervention period pre-dialysis levels of beta-2 microglobulin

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)

Time frame: 6 weeks

Pre and post 6-week intervention period pre-dialysis levels of procalcitonin

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)

Time frame: 6 weeks

Pre and post 6-week intervention period pre-dialysis levels of free light chains

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)

Time frame: 6 weeks

Pre and post 6-week intervention period pre-dialysis levels of interleukine-6

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)

Time frame: 6 weeks

Pre and post 6-week intervention period pre-dialysis levels of C reactive protein

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)

Time frame: 6 weeks

Quality of life (QoL) change (pre and at 2 weeks of intervention period)(adapted KDQoL-SF)

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.

Time frame: 2 weeks

Quality of life (QoL) change (pre and at 4 weeks of intervention period)(adapted KDQoL-SF)

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.

Time frame: 4 weeks

Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(adapted KDQoL-SF)

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.

Time frame: 4 weeks

Quality of life (QoL) change (pre and at 2 weeks of intervention period)(EQ-5D)

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.

Time frame: 2 weeks

Quality of life (QoL) change (pre and at 4 weeks of intervention period)(EQ-5D)

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.

Time frame: 4 weeks

Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(EQ-5D)

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.

Time frame: 4 weeks

Quality of life (QoL) change (pre and at 2 weeks of intervention period)(rESAS)

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.

Time frame: 2 weeks

Quality of life (QoL) change (pre and at 4 weeks of intervention period)(rESAS)

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.

Time frame: 4 weeks

Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(rESAS)

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.

Time frame: 4 weeks

Subjects's QoL questionnaire fill preference

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.

Time frame: at week 10 of study