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

Vantive Health LLC

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Device: Polyflux 210H dialyzer; Device: Polyflux HD-C4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636389

Gambro 1460

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Non-compliance with dialysis
• Hematocrit less than 28%
• Active Infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

HD-C4 First, then 210H

Other group

Description:

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.

Treatment:

Device: Polyflux HD-C4

Device: Polyflux 210H dialyzer

210H First, then HD-C4

Other group

Description:

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.

Treatment:

Device: Polyflux HD-C4

Device: Polyflux 210H dialyzer