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.

Study Overview

• Status: Completed
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Device: Dialyzer 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rostock, Germany, D-18107
    • Praxisverbund für Dialyse und Apherese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baxter Xenium XPH 210; Device: Baxter Xenium XPH 210 dialyzer	Device: Dialyzer Baxter Xenium XPH 210; High-Flux dialyzer; Other Names: Baxter Xenium XPH 210

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Praxisverbund Dialyse und Apherese
• Investigators: Principal Investigator: Peter G. Ahrenholz, PhD, BioArtProducts GmbH Rostock, Germany

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: hemodialysis; hemodiafiltration; on line; postdilution; high-flux dialyzer
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: PDA-01