End Stage Kidney DiseaseNCT00976846
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
A study testing Dialyzer Baxter Xenium XPH 210 in people with End Stage Kidney Disease, run by Praxisverbund Dialyse und Apherese at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Dialyzer Baxter Xenium XPH 210
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read 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 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.
- Conditions
- End Stage Kidney Disease
- Being tested
- Dialyzer Baxter Xenium XPH 210
- Keywords
- hemodialysis, on line, postdilution, high-flux dialyzer, hemodiafiltration
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialyzer Baxter Xenium XPH 210Device
Also called Baxter Xenium XPH 210
High-Flux dialyzer
| Study group | Role | What they receive |
|---|---|---|
| Baxter Xenium XPH 210 | Experimental | Device: Baxter Xenium XPH 210 dialyzer Receives: Device: Dialyzer Baxter Xenium XPH 210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxisverbund Dialyse und Apherese
- Sponsor type
- University, hospital or other
- Investigators
- Peter G. Ahrenholz, PhD, Principal investigator, BioArtProducts GmbH Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976846
- Sponsor's protocol ID
- PDA-01
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Investigating the Performance and Compatibility Characteristics of the Baxter Hollow Fiber Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
- ClinicalTrials.gov ID
- NCT00976846
- Acronym / sponsor ID
- PDA-01
- Conditions
- End Stage Kidney Disease
- Keywords
- hemodialysis, on line, postdilution, high-flux dialyzer, hemodiafiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Praxisverbund Dialyse und AphereseUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baxter Xenium XPH 210 | Experimental | Device: Dialyzer Baxter Xenium XPH 210Device: Baxter Xenium XPH 210 dialyzer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialyzer Baxter Xenium XPH 210Also: Baxter Xenium XPH 210High-Flux dialyzer | Device | Baxter Xenium XPH 210 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G. Ahrenholz, PhD principal investigator
BioArtProducts GmbH Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyzer Baxter Xenium XPH 210 in people with End Stage Kidney Disease, run by Praxisverbund Dialyse und Apherese at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.