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 (HD-1)

Selayang Hospital

Status: Completed

Conditions: Quality of Life; Dialysis Amyloidosis; Hemodialysis-Associated Amyloidosis

Treatments: Device: Elisio-19H; Device: Theranova 400

Study type: Interventional

Funder types: Other

Identifiers

NCT04160351

HS/CTP/HD/001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

MCO Dialyser

Experimental group

Description:

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

Treatment:

Device: Theranova 400

High Flux Dialyser

Active Comparator group

Description:

12 treatments (4 weeks) with High Flux Dialyzer

Treatment:

Device: Elisio-19H