Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane

Study Overview
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Brief Summary
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The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

Detailed Description
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The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.

Official Title
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Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)

Conditions
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End Stage Renal Disease, Renal Failure

Intervention / Treatment
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* Device: Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years Informed consent signed and dated by study patient and investigator / authorized physician Ability to understand the nature and requirements of the study Exclusion Criteria: Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.). Ongoing participation in an interventional clinical study during the preceding 30 days Previous participation in this study Pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period

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
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemodiafiltration HDF<br>Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration sessions with the dialyzer FX CORAL 600 (TD 16-1), the dialyzer FX CorDiax 600 or the dialyzer FX 600. In each week the patient is assigned to one type of dialyzer. | Device: Dialyzer<br>* Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal rate of 2-microglobulin | Removal rate of 2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX Coral 600 (TD 16-1) dialyzer. | t=240 min. of HDF | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of ß2-microglobulin |  | t=60 min. of HDF | 
| Removal rates of myoglobin |  | t=240 min. of HDF | 
| Clearances of myoglobin |  | t= 60 min. of HDF | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Hemodiafiltration, Renal replacement therapy