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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life

Intervention / Treatment
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* Device: Theranova 400
* Device: Elisio-19H


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or above End stage kidney failure receiving hemodialysis for at least 3 years Currently receiving hemodialysis at our center regularly Written informed consent Exclusion Criteria: Patients with hemodiafiltration Catheter-related blood stream infection in the preceding 4 weeks Malfunctioning of HD catheter Planned transfer to peritoneal dialysis or transplant within 90 days Pregnancy History of active alcohol or substance abuse in the previous 6 months Concurrent participation in another interventional study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCO Dialyser<br>12 treatments (4 weeks) with Medium Cut-Off Dialyzer | Device: Theranova 400<br>* medium cut-off dialyser<br>|
| Active Comparator: High Flux Dialyser<br>12 treatments (4 weeks) with High Flux Dialyzer | Device: Elisio-19H<br>* high flux dialyser<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life