End Stage Renal Disease on DialysisNCT03618368
Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
A study testing THERANOVA-500 dialyzer and REVACLEAR-400 dialyzer in people with End Stage Renal Disease on Dialysis, run by Réseau de Santé Vitalité Health Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- THERANOVA-500 dialyzer and REVACLEAR-400 dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2018to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3
About this study
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).
Read the detailed description
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:
- 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),
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded THERANOVA-500 treated subjects during the 6-week intervention period,
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded REVACLEAR-400 treated subjects during the 6-week intervention period),
- Post-hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3,
- Percentage of subjects who report no (zero) recovery time (mean THERANOVA-500 vs mean REVACLEAR-400) during 6-week intervention period (all subjects),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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
- Being tested
- THERANOVA-500 dialyzer, REVACLEAR-400 dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Blinded THERANOVA-500 dialyzer | Experimental | This group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy. Receives: Device: THERANOVA-500 dialyzer |
| Blinded REVACLEAR-400 dialyzer | Placebo comparator | This group of 25 subjects is dialyzed with masked REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD). Receives: Device: REVACLEAR-400 dialyzer |
| Unblinded THERANOVA-500 dialyzer | Experimental | This group of 10 subjects is dialyzed with unmasked THERANOVA-500 dialyzer which enables Expanded Hemodialysis (HDx) therapy. Receives: Device: THERANOVA-500 dialyzer |
| Unblinded REVACLEAR-400 dialyzer | Placebo comparator | This group of 10 subjects is dialyzed with unmasked REVACLEAR-400 dialyzer which enables conventional hemodialysis (HD). Receives: Device: REVACLEAR-400 dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through 6-week intervention period
Secondary outcomes (20)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at week 10 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start25 Jun 2018
- Primary completion23 Oct 2018
- Study completion4 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Réseau de Santé Vitalité Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Dorval, MD,MPH,MBA, Principal investigator, Dr Georges-L.-Dumont University Hospital Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618368
- Sponsor's protocol ID
- NEP2018-01
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is no plan to share individual participant data as this was not approved by local ethic review board.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
- ClinicalTrials.gov ID
- NCT03618368
- Acronym / sponsor ID
- NEP2018-01
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Réseau de Santé Vitalité Health NetworkUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 4 Jun 2021 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- 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),
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded THERANOVA-500 treated subjects during the 6-week intervention period,
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded REVACLEAR-400 treated subjects during the 6-week intervention period),
- Post-hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3,
- Percentage of subjects who report no (zero) recovery time (mean THERANOVA-500 vs mean REVACLEAR-400) during 6-week intervention period (all subjects),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- Subjects's QoL questionnaire fill preference (adapted KD QoL-SF vs EQ-5D vs rESAS) at study week 8.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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))
| Arm | Type | Receives |
|---|---|---|
| Blinded THERANOVA-500 dialyzer | Experimental | Device: THERANOVA-500 dialyzerThis group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy. |
| Blinded REVACLEAR-400 dialyzer | Placebo comparator | Device: REVACLEAR-400 dialyzerThis group of 25 subjects is dialyzed with masked REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD). |
| Unblinded THERANOVA-500 dialyzer | Experimental | Device: THERANOVA-500 dialyzerThis group of 10 subjects is dialyzed with unmasked THERANOVA-500 dialyzer which enables Expanded Hemodialysis (HDx) therapy. |
| Unblinded REVACLEAR-400 dialyzer | Placebo comparator | Device: REVACLEAR-400 dialyzerThis group of 10 subjects is dialyzed with unmasked REVACLEAR-400 dialyzer which enables conventional hemodialysis (HD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERANOVA-500 dialyzerTHERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy. | Device | Blinded THERANOVA-500 dialyzer, Unblinded THERANOVA-500 dialyzer |
| REVACLEAR-400 dialyzerREVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD). | Device | Blinded REVACLEAR-400 dialyzer, Unblinded REVACLEAR-400 dialyzer |
Primary outcome
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)
20 secondary outcomes
Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400)
Time frame: through 10-week study
Post-hemodialysis recovery time difference (THERANOVA-500)
Time frame: through 6-week intervention period
Post-hemodialysis recovery time difference (REVACLEAR-400)
Time frame: through 6-week intervention period
Post-hemodialysis recovery time difference mean gap (THERANOVA-500 vs REVACLEAR-400)
Time frame: through 6-week intervention period
Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400)
Time frame: through 6-week intervention period
Pre and post 6-week intervention period pre-dialysis levels of beta-2 microglobulin
Time frame: 6 weeks
Pre and post 6-week intervention period pre-dialysis levels of procalcitonin
Time frame: 6 weeks
Pre and post 6-week intervention period pre-dialysis levels of free light chains
Time frame: 6 weeks
Pre and post 6-week intervention period pre-dialysis levels of interleukine-6
Time frame: 6 weeks
Pre and post 6-week intervention period pre-dialysis levels of C reactive protein
Time frame: 6 weeks
Quality of life (QoL) change (pre and at 2 weeks of intervention period)(adapted KDQoL-SF)
Time frame: 2 weeks
Quality of life (QoL) change (pre and at 4 weeks of intervention period)(adapted KDQoL-SF)
Time frame: 4 weeks
Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(adapted KDQoL-SF)
Time frame: 4 weeks
Quality of life (QoL) change (pre and at 2 weeks of intervention period)(EQ-5D)
Time frame: 2 weeks
Quality of life (QoL) change (pre and at 4 weeks of intervention period)(EQ-5D)
Time frame: 4 weeks
Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(EQ-5D)
Time frame: 4 weeks
Quality of life (QoL) change (pre and at 2 weeks of intervention period)(rESAS)
Time frame: 2 weeks
Quality of life (QoL) change (pre and at 4 weeks of intervention period)(rESAS)
Time frame: 4 weeks
Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(rESAS)
Time frame: 4 weeks
Subjects's QoL questionnaire fill preference
Time frame: at week 10 of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No. This is no plan to share individual participant data as this was not approved by local ethic review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Dorval, MD,MPH,MBA principal investigator
Dr Georges-L.-Dumont University Hospital Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERANOVA-500 dialyzer and REVACLEAR-400 dialyzer in people with End Stage Renal Disease on Dialysis, run by Réseau de Santé Vitalité Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dialysis recovery time (intervention period) (time frame: through 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.