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

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 In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04160351

Acronym

HD-1

Enrollment

Registered

2019-11-13

Start date

2019-12-01

Completion date

2021-12-31

Last updated

2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Amyloidosis, Hemodialysis-Associated Amyloidosis, Quality of Life

Keywords

Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life

Brief 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.

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.

Interventions

DEVICETheranova 400

medium cut-off dialyser

DEVICEElisio-19H

high flux dialyser

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Removal of Beta-2-microglobulin	4 weeks	Changes to Beta-2-microglobulin level
Changes to Quality of Life	27 weeks	Changes to Quality of life Using SF-36

Secondary

Measure	Time frame	Description
Inflammatory state after intervention	4 weeks	Changes to C-Reactive Protein Level
Changes to Quality of Life	27 weeks	Changes to Quality of life Using EQ-5D-5L

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026