ClinicalTrials.gg
Sign In
CompletedNCT04160351HD-1Updated May 19, 2022

A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis

An interventional study of Theranova 400 and Elisio-19H in Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis and Quality of Life, sponsored by Selayang Hospital. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by Selayang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Read the detailed description

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.

02

Conditions studied

  • Hemodialysis-Associated Amyloidosis
  • Dialysis Amyloidosis
  • Quality of Life

Keywords

  • Hemodialysis-Associated Amyloidosis
  • Dialysis Amyloidosis
  • Quality of Life
03

In context

Lead sponsor

Selayang Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18 years of age or above
  2. End stage kidney failure receiving hemodialysis for at least 3 years
  3. Currently receiving hemodialysis at our center regularly
  4. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Patients with hemodiafiltration
  2. Catheter-related blood stream infection in the preceding 4 weeks
  3. Malfunctioning of HD catheter
  4. Planned transfer to peritoneal dialysis or transplant within 90 days
  5. Pregnancy
  6. History of active alcohol or substance abuse in the previous 6 months
  7. Concurrent participation in another interventional study
  8. Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    MCO Dialyser

    12 treatments (4 weeks) with Medium Cut-Off Dialyzer

    Device: Theranova 400

  • Active comparator
    High Flux Dialyser

    12 treatments (4 weeks) with High Flux Dialyzer

    Device: Elisio-19H

Interventions

  • DeviceTheranova 400

    medium cut-off dialyser

  • DeviceElisio-19H

    high flux dialyser

06

What researchers measure

Primary outcomes

  1. Removal of Beta-2-microglobulin

    Changes to Beta-2-microglobulin level

    Time frame: 4 weeks

  2. Changes to Quality of Life

    Changes to Quality of life Using SF-36

    Time frame: 27 weeks

Secondary outcomes

  1. Inflammatory state after intervention

    Changes to C-Reactive Protein Level

    Time frame: 4 weeks

  2. Changes to Quality of Life

    Changes to Quality of life Using EQ-5D-5L

    Time frame: 27 weeks

07

Study locations

1 site
  • Selayang Hospital
    Batu Caves, Selangor 68100, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2019 to primary completion in Jun 2020, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2019
First posted
Nov 13, 2019
StartActual
Dec 1, 2019
Primary completionActual
Jun 1, 2020
CompletionActual
Dec 31, 2021
Last update
May 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04160351
Lead sponsor
Selayang Hospital
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Dec 1, 2019
Primary completion
Jun 1, 2020
Completion
Dec 31, 2021
Last update
May 19, 2022

Study contacts

Hin Seng Wong, MD
study director · Ministry of Health, Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Selayang Hospital

Start the discussion