In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

Detailed Description
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Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

Official Title
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In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: Elisio-210H
* Procedure: conventional hemodialysis
* Procedure: on line hemodiafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD dialysis patients on treatment with three times a week HD for more than three months with a stable anticoagulation scheme with haemoglobin level >10.5 g/dL with vascular access allowing a stable blood flow of 300 mL/min during treatment Exclusion Criteria: patient already enrolled in another study pregnancy symptoms or signs of acute/chronic inflammatory or infectious diseases

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elisio-210H with HD<br>hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer | Device: Elisio-210H<br>* comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration<br>Procedure: conventional hemodialysis<br>* comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer<br>|
| Active Comparator: Elisio-210H with on line HDF<br>hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer | Device: Elisio-210H<br>* comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration<br>Procedure: on line hemodiafiltration<br>* comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-dialytic serum beta-2 microglobulin level |  | Month 1 (after one month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction rate of low molecular weight solutes (urea and creatinine) |  | Month 0, 1, 2, 3, 4 | 
| dialysis dose (urea KT/V) |  | Month 0, 1, 2, 3, 4 | 
| instantaneous clearance of low molecular weight solutes (urea and creatinine) |  | Month 0, 1, 2, 3, 4 | 
| inflammatory markers (CRP, fibrinogen, orosomucoide) |  | month 0, 1, 2, 3, 4 | 
| inflammatory marker (interkeukin 6) |  | month 0, 4 | 
| nutritional status (albumin, transthyretin, homocysteine) |  | Month 0, 1, 2, 3, 4 | 
| endothelial progenitor cells |  | Month 0, 1, 2, 3, 4 | 
| inflammatory mononuclear cell activation |  | Month 0, 1, 2, 3, 4 | 
| kappa and lambda light chains |  | Month 0, 4 | 
| oxidative stress parameters (superoxide anion, AOPPs, AGEs) |  | Month 0, 4 | 
| coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII) |  | Month 0, 4 | 
| apoptosis markers (soluble FAS and FAS ligand) |  | Month 0, 4 | 
| bone markers (bone PAL, Cross Laps, TRAP5b) |  | Month 0, 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility