Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Study Overview
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Brief Summary
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The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.

Official Title
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Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hemodialysis patients 18 years and older treated by post dilution on-line Hemodiafiltration (HDF) for at least one month who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks who are on a stable anticoagulation and anemia management whose hemoglobin is between 10.5 and 13.0 g/dl who are clinically stable based on judgment of nephrologist who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday, who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min) who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent Exclusion Criteria: Patients with active Hepatitis B, Hepatitis C or HIV infection who are severely malnourished as judged by the principal investigator who are known or suspected to have allergy to the trial products or related products with a central venous catheter based vascular access who are abusing non-legal drugs or alcohol who have currently active malignant disease who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding who participate simultaneously in another clinical investigation who have participated in othe clinical investigations during the last month who are uncooperative

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FX 100 dialyzer<br> | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)<br>* 4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements<br>|
| Other: Polyflux 210 H dialyzer<br> | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)<br>* 4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements<br>|
| Other: FXCorDiax 100 dialyzer<br> | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)<br>* 4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance and removal rate of phosphate, beta2 microglobulin and leptin | during a 4 hour online hemodiafiltration session | 4 hour |