N/A N=12 Randomized Treatment

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

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00636389 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Polyflux 210H dialyzer (Device); Polyflux HD-C4 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vantive Health LLC
Primary completion: Dec 2008

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	—

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.

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.