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

End Stage Kidney Disease Clinical Trial

Official title:

Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976846
• Other study ID #: PDA-01
• Status: Completed
• Phase: N/A
• First received: September 10, 2009
• Last updated: September 14, 2009
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Praxisverbund Dialyse und Apherese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Dialyzer Baxter Xenium XPH 210
High-Flux dialyzer

Locations

Country	Name	City	State
Germany	Praxisverbund für Dialyse und Apherese	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
Praxisverbund Dialyse und Apherese

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		3 weeks	Yes
Secondary	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		3 weeks	No