Chronic Kidney DiseaseNCT01653808
In Vivo Evaluation of the Nipro Elisio™ Dialyzer
A study testing Elisio-210H, conventional hemodialysis and on line hemodiafiltration in people with Chronic Kidney Disease, run by Nipro Europe N.V. at 1 site in France.
Trial summary
The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Elisio-210H, conventional hemodialysis and on line hemodiafiltration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD dialysis patients on treatment with three times a week HD for more than three months
- with a stable anticoagulation scheme
- with haemoglobin level >10.5 g/dL
- with vascular access allowing a stable blood flow of 300 mL/min during treatment
Who cannot join
- patient already enrolled in another study
- pregnancy
- symptoms or signs of acute/chronic inflammatory or infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
Read the detailed description
Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.
- Conditions
- Chronic Kidney Disease
- Being tested
- Elisio-210H, conventional hemodialysis, on line hemodiafiltration
- Keywords
- CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elisio-210HDevice
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
conventional hemodialysisProcedure or surgery
comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
on line hemodiafiltrationProcedure or surgery
comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer
| Study group | Role | What they receive |
|---|---|---|
| Elisio-210H with HD | Experimental | hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer Receives: Device: Elisio-210H; Procedure: conventional hemodialysis |
| Elisio-210H with on line HDF | Active comparator | hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer Receives: Device: Elisio-210H; Procedure: on line hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-dialytic serum beta-2 microglobulin level
Measured: Month 1 (after one month)
Secondary outcomes (13)
reduction rate of low molecular weight solutes (urea and creatinine)
Measured: Month 0, 1, 2, 3, 4
dialysis dose (urea KT/V)
Measured: Month 0, 1, 2, 3, 4
instantaneous clearance of low molecular weight solutes (urea and creatinine)
Measured: Month 0, 1, 2, 3, 4
inflammatory markers (CRP, fibrinogen, orosomucoide)
Measured: month 0, 1, 2, 3, 4
inflammatory marker (interkeukin 6)
Measured: month 0, 4
nutritional status (albumin, transthyretin, homocysteine)
Measured: Month 0, 1, 2, 3, 4
endothelial progenitor cells
Measured: Month 0, 1, 2, 3, 4
inflammatory mononuclear cell activation
Measured: Month 0, 1, 2, 3, 4
kappa and lambda light chains
Measured: Month 0, 4
oxidative stress parameters (superoxide anion, AOPPs, AGEs)
Measured: Month 0, 4
coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)
Measured: Month 0, 4
apoptosis markers (soluble FAS and FAS ligand)
Measured: Month 0, 4
bone markers (bone PAL, Cross Laps, TRAP5b)
Measured: Month 0, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nipro Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard CANAUD, MD, Prof., Principal investigator, University Hospital Center of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653808
- Sponsor's protocol ID
- Nipro-Elisio 210H
- Status last verified
- Nov 2008
- First submitted
- 27 Jul 2012
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of the Nipro Elisio™ Dialyzer
- ClinicalTrials.gov ID
- NCT01653808
- Acronym / sponsor ID
- Nipro-Elisio 210H
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nipro Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Jul 2012 (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 purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
Detailed description
Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elisio-210H with HD | Experimental | Device: Elisio-210H, Procedure: conventional hemodialysishemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer |
| Elisio-210H with on line HDF | Active comparator | Device: Elisio-210H, Procedure: on line hemodiafiltrationhemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD dialysis patients on treatment with three times a week HD for more than three months
- with a stable anticoagulation scheme
- with haemoglobin level >10.5 g/dL
- with vascular access allowing a stable blood flow of 300 mL/min during treatment
Key exclusion criteria (3 listed)
- patient already enrolled in another study
- pregnancy
- symptoms or signs of acute/chronic inflammatory or infectious diseases
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 |
|---|---|---|
| Elisio-210Hcomparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration | Device | Elisio-210H with HD, Elisio-210H with on line HDF |
| conventional hemodialysiscomparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer | Procedure or surgery | Elisio-210H with HD |
| on line hemodiafiltrationcomparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer | Procedure or surgery | Elisio-210H with on line HDF |
Primary outcome
pre-dialytic serum beta-2 microglobulin level
Time frame: Month 1 (after one month)
13 secondary outcomes
reduction rate of low molecular weight solutes (urea and creatinine)
Time frame: Month 0, 1, 2, 3, 4
dialysis dose (urea KT/V)
Time frame: Month 0, 1, 2, 3, 4
instantaneous clearance of low molecular weight solutes (urea and creatinine)
Time frame: Month 0, 1, 2, 3, 4
inflammatory markers (CRP, fibrinogen, orosomucoide)
Time frame: month 0, 1, 2, 3, 4
inflammatory marker (interkeukin 6)
Time frame: month 0, 4
nutritional status (albumin, transthyretin, homocysteine)
Time frame: Month 0, 1, 2, 3, 4
endothelial progenitor cells
Time frame: Month 0, 1, 2, 3, 4
inflammatory mononuclear cell activation
Time frame: Month 0, 1, 2, 3, 4
kappa and lambda light chains
Time frame: Month 0, 4
oxidative stress parameters (superoxide anion, AOPPs, AGEs)
Time frame: Month 0, 4
coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)
Time frame: Month 0, 4
apoptosis markers (soluble FAS and FAS ligand)
Time frame: Month 0, 4
bone markers (bone PAL, Cross Laps, TRAP5b)
Time frame: Month 0, 4
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 14 Sep 2012.
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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.
Bernard CANAUD, MD, Prof. principal investigator
University Hospital Center of Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elisio-210H, conventional hemodialysis and on line hemodiafiltration in people with Chronic Kidney Disease, run by Nipro Europe N.V. at 1 site in France.
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 4 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 14 Sep 2012. 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 France. 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?
pre-dialytic serum beta-2 microglobulin level (time frame: Month 1 (after one month)). 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 14 Sep 2012.