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

Quality of Life Clinical Trial

— HD-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160351
• Other study ID #: HS/CTP/HD/001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Selayang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Theranova 400
medium cut-off dialyser
• Elisio-19H
high flux dialyser

Locations

Country	Name	City	State
Malaysia	Selayang Hospital	Batu Caves	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
Selayang Hospital

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of Beta-2-microglobulin	Changes to Beta-2-microglobulin level	4 weeks
Primary	Changes to Quality of Life	Changes to Quality of life Using SF-36	27 weeks
Secondary	Inflammatory state after intervention	Changes to C-Reactive Protein Level	4 weeks
Secondary	Changes to Quality of Life	Changes to Quality of life Using EQ-5D-5L	27 weeks