N/A Completed N=12 Randomized Treatment

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

Source: ClinicalTrials.gov NCT00636389 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcomePrimary: Comparison of Urea Removal Under Conditions of Routine Hemodialysis. — 1.64; 1.61; 1.42; 1.40 ratio

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of Urea Removal Under Conditions of Routine Hemodialysis.	1.64; 1.61; 1.42; 1.40	—
PRIMARY A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.	74; 74; 61; 60; 52; 58	—
SECONDARY Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H	1.19; 1.47; 1.36; 1.51; 1.42; 1.78	—

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00636389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.