End Stage Renal Failure on DialysisNCT01273870
Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
An observational study of End Stage Renal Failure on Dialysis, run by Praxisverbund Dialyse und Apherese.
Trial summary
The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Feb 2011
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 8 patients will undergo 1 treatment each with the 4 high-flux dialyzer types using a bloodflow of 300 ml/min, dialysate flow 500 ml/min and the dialysis machine Fresenius 5008
Who may be able to join
- ESRD patients 18 years or older
- Stable on hemodialysis for more than 3 months
- An average haematocrit value of 30 % or higher in the last three 3 months
- Stable vascular access of either a fistula or graft
- Stable anticoagulation and regimen
- Stable erythropoiesis-stimulating agent (ESA) regimen for the last three 3 months
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- No active infection
- Able to sign informed consent and able to participate in the study
- Medically stable
Who cannot join
- Participation in another study which may interfere with the planned study
- Active infection
- Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
- Female(s) who are pregnant or planning to be pregnant
- Problem with or allergy to anticoagulation
- Central venous catheters
About this study
Official title: Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers
Read the detailed description
The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro testing, and all legally required biological safety tests have been conducted and CE-mark was granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of dialyzers which has been available commercially globally for approximately three years. Clinical evaluations have been completed with the Polynephron membrane within the last three years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.
The aim of the dialyzer evaluation is to compare performance characteristics and hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- hemodialysis, high-flux-dialyzer, performance, blood compatibility
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
Measured: January 2011
Secondary outcomes (1)
General survey of the dialysis treatments
Registration of adverse effects of the dialysis treatments
Measured: January 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxisverbund Dialyse und Apherese
- Sponsor type
- University, hospital or other
- Investigators
- Roland E Winkler, PhD, Study director, Praxisverbund fuer Dialyse und Apherese Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273870
- Sponsor's protocol ID
- PDA-02
- Status last verified
- Nov 2010
- First submitted
- 22 Dec 2010
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
- ClinicalTrials.gov ID
- NCT01273870
- Acronym / sponsor ID
- PDA-02
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- hemodialysis, high-flux-dialyzer, performance, blood compatibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Praxisverbund Dialyse und AphereseUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jan 2011 (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 aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers
Detailed description
The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro testing, and all legally required biological safety tests have been conducted and CE-mark was granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of dialyzers which has been available commercially globally for approximately three years. Clinical evaluations have been completed with the Polynephron membrane within the last three years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.
The aim of the dialyzer evaluation is to compare performance characteristics and hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 8 patients will undergo 1 treatment each with the 4 high-flux dialyzer types using a bloodflow of 300 ml/min, dialysate flow 500 ml/min and the dialysis machine Fresenius 5008
Key inclusion criteria (9 listed)
- ESRD patients 18 years or older
- Stable on hemodialysis for more than 3 months
- An average haematocrit value of 30 % or higher in the last three 3 months
- Stable vascular access of either a fistula or graft
- Stable anticoagulation and regimen
Key exclusion criteria (6 listed)
- Participation in another study which may interfere with the planned study
- Active infection
- Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
- Female(s) who are pregnant or planning to be pregnant
- Problem with or allergy to anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
Time frame: January 2011
1 secondary outcome
General survey of the dialysis treatments
Time frame: January 2011
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 2 Feb 2011.
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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.
Roland E Winkler, PhD study director
Praxisverbund fuer Dialyse und Apherese Rostock
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure on Dialysis, run by Praxisverbund Dialyse und Apherese.
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 9 inclusion and 6 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 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT (time frame: January 2011). 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 2 Feb 2011.