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

This study has been completed.
Sponsor:
Information provided by:
Praxisverbund Dialyse und Apherese
ClinicalTrials.gov Identifier:
NCT00976846
First received: September 10, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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 Intervention
End Stage Kidney Disease
Device: Dialyzer Baxter Xenium XPH 210

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Praxisverbund Dialyse und Apherese:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976846

Locations
Germany
Praxisverbund für Dialyse und Apherese
Rostock, Germany, D-18107
Sponsors and Collaborators
Praxisverbund Dialyse und Apherese
Investigators
Principal Investigator: Peter G. Ahrenholz, PhD BioArtProducts GmbH Rostock, Germany
  More Information

No publications provided

Responsible Party: Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany
ClinicalTrials.gov Identifier: NCT00976846     History of Changes
Other Study ID Numbers: PDA-01
Study First Received: September 10, 2009
Last Updated: September 14, 2009
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Praxisverbund Dialyse und Apherese:
hemodialysis
on line
postdilution
high-flux dialyzer
hemodiafiltration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 20, 2014