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

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ClinicalTrials.gov Identifier: NCT03618368
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Réseau de Santé Vitalité Health Network

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis Device: THERANOVA-500 dialyzer Device: REVACLEAR-400 dialyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

1 blinded group on THERANOVA-500 dialyzer (Expanded Hemodialysis (HDx))

1 blinded group on REVACLEAR-400 dialyzer (conventional hemodialysis (HD))

1 non-blinded group on THERANOVA-500 dialyzer (Expanded Hemodialysis (HDx))

1 non-blinded group on REVACLEAR-400 dialyzer (conventional hemodialysis (HD))

Masking: Single (Participant)
Masking Description: blinded group: as dialyzers are almost identical except for their labels, blinding is achieved by masking dialyzer labels.
Primary Purpose: Other
Official Title: Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : October 23, 2018
Estimated Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Blinded THERANOVA-500 dialyzer
This group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy.
Device: THERANOVA-500 dialyzer
THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.

Placebo Comparator: Blinded REVACLEAR-400 dialyzer
This group of 25 subjects is dialyzed with masked REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD).
Device: REVACLEAR-400 dialyzer
REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).

Experimental: Unblinded THERANOVA-500 dialyzer
This group of 10 subjects is dialyzed with unmasked THERANOVA-500 dialyzer which enables Expanded Hemodialysis (HDx) therapy.
Device: THERANOVA-500 dialyzer
THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.

Placebo Comparator: Unblinded REVACLEAR-400 dialyzer
This group of 10 subjects is dialyzed with unmasked REVACLEAR-400 dialyzer which enables conventional hemodialysis (HD).
Device: REVACLEAR-400 dialyzer
REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).




Primary Outcome Measures :
  1. Post-dialysis recovery time (intervention period) [ Time Frame: through 6-week 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)


Secondary Outcome Measures :
  1. Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400) [ Time Frame: through 10-week study ]
    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)

  2. Post-hemodialysis recovery time difference (THERANOVA-500) [ Time Frame: through 6-week intervention period ]
    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.

  3. Post-hemodialysis recovery time difference (REVACLEAR-400) [ Time Frame: through 6-week intervention period ]
    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.

  4. Post-hemodialysis recovery time difference mean gap (THERANOVA-500 vs REVACLEAR-400) [ Time Frame: through 6-week intervention period ]
    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.

  5. Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400) [ Time Frame: through 6-week intervention period ]
    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)

  6. Pre and post 6-week intervention period pre-dialysis levels of beta-2 microglobulin [ Time Frame: 6 weeks ]
    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)

  7. Pre and post 6-week intervention period pre-dialysis levels of procalcitonin [ Time Frame: 6 weeks ]
    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)

  8. Pre and post 6-week intervention period pre-dialysis levels of free light chains [ Time Frame: 6 weeks ]
    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)

  9. Pre and post 6-week intervention period pre-dialysis levels of interleukine-6 [ Time Frame: 6 weeks ]
    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)

  10. Pre and post 6-week intervention period pre-dialysis levels of C reactive protein [ Time Frame: 6 weeks ]
    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)

  11. Quality of life (QoL) change (pre and at 2 weeks of intervention period)(adapted KDQoL-SF) [ Time Frame: 2 weeks ]
    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.

  12. Quality of life (QoL) change (pre and at 4 weeks of intervention period)(adapted KDQoL-SF) [ Time Frame: 4 weeks ]
    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.

  13. Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(adapted KDQoL-SF) [ Time Frame: 4 weeks ]
    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.

  14. Quality of life (QoL) change (pre and at 2 weeks of intervention period)(EQ-5D) [ Time Frame: 2 weeks ]
    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.

  15. Quality of life (QoL) change (pre and at 4 weeks of intervention period)(EQ-5D) [ Time Frame: 4 weeks ]
    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.

  16. Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(EQ-5D) [ Time Frame: 4 weeks ]
    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.

  17. Quality of life (QoL) change (pre and at 2 weeks of intervention period)(rESAS) [ Time Frame: 2 weeks ]
    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.

  18. Quality of life (QoL) change (pre and at 4 weeks of intervention period)(rESAS) [ Time Frame: 4 weeks ]
    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.

  19. Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(rESAS) [ Time Frame: 4 weeks ]
    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.

  20. Subjects's QoL questionnaire fill preference [ Time Frame: at week 10 of study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618368


Locations
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Canada, New Brunswick
Dr Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, Canada, E1C 2Z3
Sponsors and Collaborators
Réseau de Santé Vitalité Health Network
Investigators
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Principal Investigator: Marc Dorval, MD,MPH,MBA Dr Georges-L.-Dumont University Hospital Centre
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Responsible Party: Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier: NCT03618368    
Other Study ID Numbers: NEP2018-01
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is no plan to share individual participant data as this was not approved by local ethic review board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency