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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

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

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Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Dialyser

FX CorDiax 60 dialyzer

Group Type ACTIVE_COMPARATOR

dialyzer comparison

Intervention Type OTHER

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.

Dialyzer

Intervention Type DEVICE

Comparison Dialyzer FX60 versus Cordiax60

FXDialyser

FX 60 dialyzer

Group Type ACTIVE_COMPARATOR

Dialyzer

Intervention Type DEVICE

Comparison Dialyzer FX60 versus Cordiax60

Interventions

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dialyzer comparison

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.

Intervention Type OTHER

Dialyzer

Comparison Dialyzer FX60 versus Cordiax60

Intervention Type DEVICE

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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No