Status:
COMPLETED
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
Lead Sponsor:
Praxisverbund Dialyse und Apherese
Conditions:
End Stage Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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 remov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00976846
Start Date
June 1 2009
End Date
July 1 2009
Last Update
September 15 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Praxisverbund für Dialyse und Apherese
Rostock, Germany, D-18107