Performance Comparison of Revaclear With Larger Dialyzer

Study Overview
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Brief Summary
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The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area. Study design: open, randomized, cross-over, multicentric, controlled prospective Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs Patients/sample size: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers. Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss Primary variable: dialysis dose Kt/V urea Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin Safety variable: albumin loss, blood count

Official Title
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HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Other: Dialyzer comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months patients aged 18 years or more written consent to participate in the study (informed consent) dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min Exclusion Criteria: single-needle dialysis pregnant and lactating women participation in other interventional studies less than 3 months prior to study start non-compliance with the dialysis prescription hematocrit less than 28% hospitalization antibiotic therapy active infection active cancer known positive serology for HIV, hepatitis B or C serious hemostasis disorders any comorbidity possibly conflicting with the study purpose or procedures

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: Revaclear followed by FX<br> | Other: Dialyzer comparison<br>* Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX). The order of dialyzers used will be randomly assigned to the patient at randomization.<br>|
| Other: FX followed by Revaclear<br> | Other: Dialyzer comparison<br>* Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX). The order of dialyzers used will be randomly assigned to the patient at randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis dose Kt/V urea | Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure. | 2 weeks (6 consecutive dialysis sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction rate of urea, creatinine, phosphate and ß2-microglobulin | Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%). | 2 weeks (6 consecutive dialysis sessions) | 
| Total removal of creatinine, phosphate and ß2-microglobulin | Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment. | 2 weeks (6 consecutive dialysis sessions) | 
| Albumin loss | Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment. | 2 weeks (6 consecutive dialysis sessions) |