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

NCT03618368 | Unknown

• 1 other identifier: NEP2018-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• 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)

  through 6-week intervention period

Secondary Outcomes (20)

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

  through 10-week study

• Post-hemodialysis recovery time difference (THERANOVA-500)

  through 6-week intervention period

• Post-hemodialysis recovery time difference (REVACLEAR-400)

  through 6-week intervention period

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

  through 6-week intervention period

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

  through 6-week intervention period

Study Arms (4)

Blinded THERANOVA-500 dialyzer

EXPERIMENTAL

This group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy.

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).

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.

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).

Device: REVACLEAR-400 dialyzer

Interventions

THERANOVA-500 dialyzer DEVICE

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

Blinded THERANOVA-500 dialyzer; Unblinded THERANOVA-500 dialyzer

REVACLEAR-400 dialyzer DEVICE

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

Blinded REVACLEAR-400 dialyzer; Unblinded REVACLEAR-400 dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Réseau de Santé Vitalité Health Network: lead

Study Sites (1)

Dr Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3, Canada

Location

Study Officials

• Marc Dorval, MD,MPH,MBA

  Dr Georges-L.-Dumont University Hospital Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: blinded group: as dialyzers are almost identical except for their labels, blinding is achieved by masking dialyzer labels.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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))

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: August 7, 2018
• Study Start: June 25, 2018
• Primary Completion: October 23, 2018
• Study Completion: June 4, 2021
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)