Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer

Study Overview
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Brief Summary
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Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type. Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration. Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects

Official Title
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Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer

Conditions
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Hemodialysis

Intervention / Treatment
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* Other: dialyzer comparison
* Device: Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are treated by post dilution on-line HDF for at least three months. Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks, Patients who are on a stable anticoagulation and anemia management, Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator, Patients who are on a regular thrice weekly HDF schedule, Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min), Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent, Patients who are aged 18 years or older. Exclusion Criteria: Patients who do not meet the inclusion criteria, Patients with active HBV, HCV, HIV infection, Patients who are severely malnourished patients as judged by the principal investigator, Patients who are known or suspected to have allergy to the trial products or related products, Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages), Patients who have been diagnosed a current active malignant disease, Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month, Patients who are uncooperative.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dialyser<br>FX CorDiax 60 dialyzer | Other: dialyzer comparison<br>* Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.<br>Device: Dialyzer<br>* Comparison Dialyzer FX60 versus Cordiax60<br>|
| Active Comparator: FXDialyser<br>FX 60 dialyzer | Device: Dialyzer<br>* Comparison Dialyzer FX60 versus Cordiax60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal rate of myoglobin |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal rate of urea |  | 2 weeks | 
| Removal rate of phosphate |  | 2 weeks | 
| Removal rate of ß2-microglobulin (ß2-m) |  | 2 weeks | 
| Removal rate of prolactin |  | 2 weeeks | 
| Removal rate of alpha1-microglobulin |  | 2 weeks | 
| Removal rate of alpha1-acid glycoprotein |  | 2 weeks | 
| Hematocrit pre and post-dialysis |  | 2 weeks | 
| Albumin loss during dialysis session |  | 2 weeks |