Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
The proposed study seeks to determine the appropriate balance between the removal of undesirable small molecular substances (urea, creatinine, phosphate) and large molecular substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the possibility of the removal of certain protein-bound substances shall be investigated together with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration|
- Concentration of urea, creatinine, phosphate and ß2-m (pre/post treatment in blood), concentration of albumin (pre/post treatment in blood and dialysate), hematocrit pre/post treatment (for correction of the impact of ultrafiltration on concentrations) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Pre and post treatment: CMPF (metabolite of furan fatty acids), p-cresol, albumin binding capacity (ABIC) in blood and dialysate, pre and post treatment: IL-6, IL-1ß, sVCAM-1, sICAM-1, CD14+/CD16+, CD62L+, CD11b+ in blood [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Baxter Xenium XPH 210
Device: Baxter Xenium XPH 210 dialyzer
Device: Dialyzer Baxter Xenium XPH 210
Other Name: Baxter Xenium XPH 210
The new high flux dialyser membrane Xenium XPH 210 from Baxter will show an considerably increased removal of ß2-Microglobulin with olHDF in post dilution mode together with a markedly increased removal of small molecules (urea, creatinine, phosphate). The loss of albumin will depend on the treatment modalities. However, the albumin permeability is tolerable over the whole range of total filtration rate selected and applied to the patients.
Together with the albumin loss into the filtrate/dialysate a small amount of albuminbound substances is detectable.
Parameters of micro-inflammation can be influenced by an increasing convective part of the treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976846
|Praxisverbund für Dialyse und Apherese|
|Rostock, Germany, D-18107|
|Principal Investigator:||Peter G. Ahrenholz, PhD||BioArtProducts GmbH Rostock, Germany|