Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-03-31

Brief Summary

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The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device.

The objectives of this study are:

1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and,
2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HD-C4 First, then 210H

Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects will be switched to the Polyflux 210H dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments.

Group Type OTHER

Polyflux 210H dialyzer

Intervention Type DEVICE

Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Polyflux HD-C4

Intervention Type DEVICE

Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.

210H First, then HD-C4

Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects will be switched to the Polyflux HD-C4 dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments.

Group Type OTHER

Polyflux 210H dialyzer

Intervention Type DEVICE

Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Polyflux HD-C4

Intervention Type DEVICE

Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Interventions

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Polyflux 210H dialyzer

Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Intervention Type DEVICE

Polyflux HD-C4

Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Intervention Type DEVICE

Other Intervention Names

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Gambro Polyflux 210H dialyzer Gambro Revaclear

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years of age or older
* Stable hemodialysis prescription using Polyflux 210H or Polyflux 21R for at least 2 months prior to study enrollment
* Dialyzing through a native fistula or Gore-Tex graft.
* Blood access must be able to provide a blood flow rate of 400 ml/min.