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

Primary Purpose

End Stage Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dialyzer Baxter Xenium XPH 210
Sponsored by
Praxisverbund Dialyse und Apherese
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease focused on measuring hemodialysis, on line, postdilution, high-flux dialyzer, hemodiafiltration

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Praxisverbund für Dialyse und Apherese

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baxter Xenium XPH 210

Arm Description

Device: Baxter Xenium XPH 210 dialyzer

Outcomes

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)

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

Full Information

First Posted
September 10, 2009
Last Updated
September 14, 2009
Sponsor
Praxisverbund Dialyse und Apherese
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1. Study Identification

Unique Protocol Identification Number
NCT00976846
Brief Title
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
Official Title
Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Praxisverbund Dialyse und Apherese

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
hemodialysis, on line, postdilution, high-flux dialyzer, hemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baxter Xenium XPH 210
Arm Type
Experimental
Arm Description
Device: Baxter Xenium XPH 210 dialyzer
Intervention Type
Device
Intervention Name(s)
Dialyzer Baxter Xenium XPH 210
Other Intervention Name(s)
Baxter Xenium XPH 210
Intervention Description
High-Flux dialyzer
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G. Ahrenholz, PhD
Organizational Affiliation
BioArtProducts GmbH Rostock, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Praxisverbund für Dialyse und Apherese
City
Rostock
ZIP/Postal Code
D-18107
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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