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

NCT00976846 | Completed

• 1 other identifier: PDA-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Kidney Disease

Keywords

hemodialysis; on line; postdilution; high-flux dialyzer; hemodiafiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Baxter Xenium XPH 210

EXPERIMENTAL

Device: Baxter Xenium XPH 210 dialyzer

Device: Dialyzer Baxter Xenium XPH 210

Interventions

Dialyzer Baxter Xenium XPH 210 DEVICE

High-Flux dialyzer

Also known as: Baxter Xenium XPH 210

Baxter Xenium XPH 210

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Praxisverbund Dialyse und Apherese: lead

Study Sites (1)

Praxisverbund für Dialyse und Apherese

Rostock, D-18107, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter G. Ahrenholz, PhD

  BioArtProducts GmbH Rostock, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 15, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

DE (1)