Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
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|ClinicalTrials.gov Identifier: NCT00976846|
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
|Condition or disease||Intervention/treatment||Phase|
|End Stage Kidney Disease||Device: Dialyzer Baxter Xenium XPH 210||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Baxter Xenium XPH 210
Device: Baxter Xenium XPH 210 dialyzer
Device: Dialyzer Baxter Xenium XPH 210
Other Name: Baxter Xenium XPH 210
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976846
|Praxisverbund für Dialyse und Apherese|
|Rostock, Germany, D-18107|
|Principal Investigator:||Peter G. Ahrenholz, PhD||BioArtProducts GmbH Rostock, Germany|