Chronic Kidney DiseaseNCT00735059
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
A study testing treatment with the dialyzer ELISIO 170H and treatment with the dialyzer PES-170DS in people with Chronic Kidney Disease, run by EXcorLab GmbH at 1 site in Belgium.
Trial summary
A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. 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?
- treatment with the dialyzer ELISIO 170H and treatment with the dialyzer PES-170DS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2008to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
- Hematocrit >30 %
- Routine anticoagulation and erythropoietin regimen
- No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
- No ongoing infection
Show all 12Show fewer
- Signed informed consent form
- Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
- Unstable clinical condition (e.g. cardiac or vascular instability)
- Life expectancy less than 12 months
- Known coagulation problems
- Patients participating in another study interfering with the planned study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.
- Conditions
- Chronic Kidney Disease
- Being tested
- treatment with the dialyzer ELISIO 170H, treatment with the dialyzer PES-170DS
- Keywords
- dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis, protein-bound toxins, beta-2-microglobulin, hemodialysis patients
- 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.
treatment with the dialyzer ELISIO 170HDevice
one week of three consecutive dialysis treatments, > 3 hours
treatment with the dialyzer PES-170DSDevice
one week of three consecutive dialysis treatments, > 3 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | treatment with dialyzer ELISIO 170H Receives: Device: treatment with the dialyzer ELISIO 170H |
| 2 | Active comparator | treatment with dialyzer PES-170DS Receives: Device: treatment with the dialyzer PES-170DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein-bound toxin removal
Measured: pre and post dialysis treatment
low-molecular weight protein removal
Measured: pre and post dialysis treatment
small solute removal
Measured: pre and post dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionApr 2009
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EXcorLab GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Nipro Europe N.V.
- Investigators
- Raymond Vanholder, Prof. Dr., Principal investigator, University Hospital Ghent, Nephrology Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735059
- Sponsor's protocol ID
- KSEL0702
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2008
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
- ClinicalTrials.gov ID
- NCT00735059
- Acronym / sponsor ID
- KSEL0702
- Conditions
- Chronic Kidney Disease
- Keywords
- dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- EXcorLab GmbHUniversity, hospital or other
- Collaborators
- Nipro Europe N.V.
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Aug 2008 (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.
A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: treatment with the dialyzer ELISIO 170Htreatment with dialyzer ELISIO 170H |
| 2 | Active comparator | Device: treatment with the dialyzer PES-170DStreatment with dialyzer PES-170DS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years
- CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
- Hematocrit >30 %
- Routine anticoagulation and erythropoietin regimen
- No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| treatment with the dialyzer ELISIO 170Hone week of three consecutive dialysis treatments, > 3 hours | Device | 1 |
| treatment with the dialyzer PES-170DSone week of three consecutive dialysis treatments, > 3 hours | Device | 2 |
Primary outcome
protein-bound toxin removal
Time frame: pre and post dialysis treatment
low-molecular weight protein removal
Time frame: pre and post dialysis treatment
small solute removal
Time frame: pre and post dialysis treatment
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 21 Aug 2009.
Related trials for Chronic Kidney Disease
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.
Raymond Vanholder, Prof. Dr. principal investigator
University Hospital Ghent, Nephrology Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with the dialyzer ELISIO 170H and treatment with the dialyzer PES-170DS in people with Chronic Kidney Disease, run by EXcorLab GmbH at 1 site in Belgium.
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 12 inclusion and 0 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 21 Aug 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 Belgium. 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?
protein-bound toxin removal (time frame: pre and post dialysis treatment). The study lists 3 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 21 Aug 2009.