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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

September 10, 2009
September 14, 2009
June 2009
July 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00976846 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber 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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
End Stage Kidney Disease
Device: Dialyzer Baxter Xenium XPH 210
High-Flux dialyzer
Other Name: Baxter Xenium XPH 210
Experimental: Baxter Xenium XPH 210
Device: Baxter Xenium XPH 210 dialyzer
Intervention: Device: Dialyzer Baxter Xenium XPH 210
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00976846
PDA-01
No
Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany
Praxisverbund Dialyse und Apherese
Not Provided
Principal Investigator: Peter G. Ahrenholz, PhD BioArtProducts GmbH Rostock, Germany
Praxisverbund Dialyse und Apherese
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP