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Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976846
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
Information provided by:
Praxisverbund Dialyse und Apherese

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Kidney Disease Device: Dialyzer Baxter Xenium XPH 210 Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Baxter Xenium XPH 210
Device: Baxter Xenium XPH 210 dialyzer
Device: Dialyzer Baxter Xenium XPH 210
High-Flux dialyzer
Other Name: Baxter Xenium XPH 210

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have signed an informed consent form.
  • Patients between 18 and 75 years.
  • Patients who have been treated with hemodialysis for more than three months.
  • Patients who are treated three times a week for 4-5 hours.
  • Patients who are usually treated with high-flux dialyzers.
  • Patients who are on a stable anticoagulation and erythropoetin regimen.
  • Patients whose hematocrit is over 28 %.
  • Patients having no vascular access related problems.

Exclusion Criteria:

  • Patients not meeting the inclusion criteria.
  • Patients who are in a poor nutritional status as judged by the investigator.
  • Patients in a gravid state.
  • Patients with an unstable clinical condition (e.g. cardiac or vascular instability).
  • Patients whose life expectancy is less than 12 months.
  • Patients with a positive anamnesis for the first use syndrome.
  • Patients with known coagulation problems.
  • Patients who receive hemodialysis via a single dialysis needle or central venous catheter.
  • Patients participating in another study that may interfere with the outcome of the present study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00976846

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Praxisverbund für Dialyse und Apherese
Rostock, Germany, D-18107
Sponsors and Collaborators
Praxisverbund Dialyse und Apherese
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Principal Investigator: Peter G. Ahrenholz, PhD BioArtProducts GmbH Rostock, Germany
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Responsible Party: Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany Identifier: NCT00976846    
Other Study ID Numbers: PDA-01
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Keywords provided by Praxisverbund Dialyse und Apherese:
on line
high-flux dialyzer
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency