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

Not Applicable

Completed

• Conditions: Hemodialysis-Associated Amyloidosis; Dialysis Amyloidosis; Quality of Life
• Interventions: Device: Theranova 400; Device: Elisio-19H

• Registration Number: NCT04160351
• Lead Sponsor: Selayang Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-09
• Study First Posted: 2019-11-13
• Study Start: 2019-12-01
• Primary Completion: 2020-06-01
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MCO Dialyser	Theranova 400	12 treatments (4 weeks) with Medium Cut-Off Dialyzer
High Flux Dialyser	Elisio-19H	12 treatments (4 weeks) with High Flux Dialyzer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Selayang Hospital; 🇲🇾 Batu Caves, Selangor Darul Ehsan, Malaysia