Kidney Failure, ChronicPhase 4NCT00291603
Short Term Effects of FX Dialysers on QOL and Inflammation
A Phase 4 study testing FX-class of dialyser in people with Kidney Failure, Chronic, run by Sir Charles Gairdner Hospital at 1 site in Australia.
Trial summary
Background: The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- FX-class of dialyser
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2006to Dec 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18years
- Able to provide informed consent
- On haemodialysis for 3 months
Who cannot join
- Active inflammatory, infective or neoplastic process within the last 1 month
- Active major psychiatric condition
- Currently on haemodiafiltration as haemodialysis modality
Trial locations and contacts
1 site in 1 country.
Australia1 site
Joondalup Health Campus Satellite Dialysis Unit
Perth, Western Australia, 6050
About this study
Official title: Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients
Background:
The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.
Read more
The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.
These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.
Aims:
- To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
- To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.
Read the detailed description
Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study.
Inclusion criteria -
- Age >18years
- Able to provide informed consent
- On haemodialysis for 3 months
Exclusion criteria -
- Active inflammatory, infective or neoplastic process within the last 1 month
- Active major psychiatric condition
- Currently on haemodiafiltration as haemodialysis modality
Design This study will involve an unblinded, cross-over design, with patients being randomised upon entry into one of 2 groups. The 2 groups will be - 1. HF80 dialyser (this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial); and 2. FX dialyser. Patients will have baseline tests performed prior to intervention and then repeated after 3 months. At 3 months, patients will then cross-over into the other group and tests repeated after a further 6 months.
Due to the nature of the intervention, blinding will not be practical. The cross-over design will allow maximum power for this fixed and relatively small dialysis population (~50 patients).
Independent variables -
- Dialysis prescription on enrolment
- Including dialyser type (biocompatibility)
- Adequacy of dialysis
- Urea reduction ratio
- Kt/V
- Anaemia
- Including iron studies
- Including erythropoietin usage
- Calcium phosphate balance
- Including Parathyroid hormone levels
- Serum albumin
Outcome markers -
- Quality of Life (i) KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients, that will be readily comparable to other studies. (ii) Feeling thermometer
- Inflammatory markers (i) High sensitivity c-reactive protein (ii) IL-6 (iii) White cell count.
Statistical analysis:
Quality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated. Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables. STATA 8.2 will be used to assist with the analysis
- Conditions
- Kidney Failure, Chronic
- Being tested
- FX-class of dialyser
- Keywords
- dialysis, Renal Dialysis, inflammation, quality of life, End Stage Kidney Failure
- Medical subject headings
- Kidney Failure, Chronic, Inflammation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-class of dialyserDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
KD-QOL
Feeling Thermometer
Secondary outcomes (4)
IL-6
TNF-alpha
hs-CRP
white cell count
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sir Charles Gairdner Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Neil C Boudville, MD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291603
- Sponsor's protocol ID
- 2005-192
- Status last verified
- Apr 2007
- First submitted
- 13 Feb 2006
- Last updated
- 25 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients
- ClinicalTrials.gov ID
- NCT00291603
- Acronym / sponsor ID
- 2005-192
- Conditions
- Kidney Failure, Chronic
- Keywords
- dialysis, Renal Dialysis, inflammation, quality of life, End Stage Kidney Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Sir Charles Gairdner HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Feb 2006 (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.
Background:
The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.
The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.
These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.
Aims:
- To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
- To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.
Detailed description
Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study.
Inclusion criteria -
- Age >18years
- Able to provide informed consent
- On haemodialysis for 3 months
Exclusion criteria -
- Active inflammatory, infective or neoplastic process within the last 1 month
- Active major psychiatric condition
- Currently on haemodiafiltration as haemodialysis modality
Design This study will involve an unblinded, cross-over design, with patients being randomised upon entry into one of 2 groups. The 2 groups will be - 1. HF80 dialyser (this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial); and 2. FX dialyser. Patients will have baseline tests performed prior to intervention and then repeated after 3 months. At 3 months, patients will then cross-over into the other group and tests repeated after a further 6 months.
Due to the nature of the intervention, blinding will not be practical. The cross-over design will allow maximum power for this fixed and relatively small dialysis population (~50 patients).
Independent variables -
- Dialysis prescription on enrolment
- Including dialyser type (biocompatibility)
- Adequacy of dialysis
- Urea reduction ratio
- Kt/V
- Anaemia
- Including iron studies
- Including erythropoietin usage
- Calcium phosphate balance
- Including Parathyroid hormone levels
- Serum albumin
Outcome markers -
- Quality of Life (i) KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients, that will be readily comparable to other studies. (ii) Feeling thermometer
- Inflammatory markers (i) High sensitivity c-reactive protein (ii) IL-6 (iii) White cell count.
Statistical analysis:
Quality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated. Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables. STATA 8.2 will be used to assist with the analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18years
- Able to provide informed consent
- On haemodialysis for 3 months
Key exclusion criteria (3 listed)
- Active inflammatory, infective or neoplastic process within the last 1 month
- Active major psychiatric condition
- Currently on haemodiafiltration as haemodialysis modality
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 |
|---|---|---|
| FX-class of dialyser | Device | – |
Primary outcome
KD-QOL
Feeling Thermometer
4 secondary outcomes
IL-6
TNF-alpha
hs-CRP
white cell count
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 25 Apr 2007.
Related trials for Kidney Failure, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Neil C Boudville, MD principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FX-class of dialyser in people with Kidney Failure, Chronic, run by Sir Charles Gairdner Hospital at 1 site in Australia.
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 3 inclusion and 3 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 25 Apr 2007. 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
KD-QOL. The study lists 2 primary outcomes in all. 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 25 Apr 2007.