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

NCT00636389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-14

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Polyflux 210H dialyzer

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

DEVICE

Polyflux HD-C4

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

Sponsors & Collaborators

  • Gambro Renal Products, Inc.

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Harry Alcorn Jr., PharmD · Davita Clinical Research Facility

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-12-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636389 on ClinicalTrials.gov