Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers
Sponsored by Baxter Healthcare Corporation
About this trial
Last updated 8 years ago
Study ID
Gambro 1460
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 16 years ago
What is this trial 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.
What are the participation requirements?
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