End Stage Renal Disease (ESRD)NCT01783626
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)
A study testing Evodial, Evodial+ Condition B1 and Evodial+ Condition B2 in people with End Stage Renal Disease (ESRD), run by Vantive Health LLC at 1 site in France.
Trial summary
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Evodial, Evodial+ Condition B1 and Evodial+ Condition B2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Mar 2013
- 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
- Anuric patient (diuresis<300ml) ,
- ESRD patient treated for at least 3 months,
- Patient treated in HDF post-dilution,
- Vascular access functioning properly (Qb > 250 ml/min),
- Patient aged 18 years or more,
- Written consent to participate in the study (informed consent).
Who cannot join
- Patient with pre-dialytic albuminemia <3.3 g/dl(Nephelometry assay)
- Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II);
- Patient under guardianship;
- Women pregnant or breast feeding;
- Patient included in other studies that could interfere with the goals of the current study.
- Patient that are not affiliated to the health system(beneficiary or dependent).
- Patient with positive serology (HIV, Hepatitis).
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Louis-Pasteur (Cherbourg-Octeville)
Cherbourg-Octeville, 50102
About this study
Official title: Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).
Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Evodial, Evodial+ Condition B1, Evodial+ Condition B2, Evodial+ Condition C
- 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.
EvodialDevice
Evodial+ Condition B1Device
Evodial+ Condition B2Device
Evodial+ Condition CDevice
| Study group | Role | What they receive |
|---|---|---|
| Evodial | Sham comparator | Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) Receives: Device: Evodial |
| Evodial+ Condition B1 | Experimental | Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) Receives: Device: Evodial+ Condition B1 |
| Evodial+ Condition B2 | Experimental | Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) Receives: Device: Evodial+ Condition B2 |
| Evodial+ Condition C | Experimental | Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) Receives: Device: Evodial+ Condition C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Beta 2 Microglobulin elimination
Measured: Change from T0 (dialysis start) at T4 hours (dialysis stop)
Secondary outcomes (6)
Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D
Measured: Change from T0 (dialysis start) at T 4hours (dialysis stop)
Efficacy:Profile of ultrafiltrated proteins
Measured: at T4 hours
Safety: Follow-up of all AEs/SAEs
Measured: during the study period
Safety: Measurement of Albumin loss
Measured: At T4 hours
Efficacy: Cumulative Purified volume (Kt)
Measured: At T4 hours
Safety: Total protein
Measured: Change from T0 and T4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Nathalie Loughraieb, Study director, Gambro Industries
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783626
- Sponsor's protocol ID
- 1498
- Status last verified
- Mar 2025
- First submitted
- 28 Jan 2013
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01783626
- Acronym / sponsor ID
- 1498
- Conditions
- End Stage Renal Disease (ESRD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Feb 2013 (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.
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).
Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Evodial | Sham comparator | Device: EvodialPeriod I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) |
| Evodial+ Condition B1 | Experimental | Device: Evodial+ Condition B1Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) |
| Evodial+ Condition B2 | Experimental | Device: Evodial+ Condition B2Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) |
| Evodial+ Condition C | Experimental | Device: Evodial+ Condition CPeriod I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Anuric patient (diuresis<300ml) ,
- ESRD patient treated for at least 3 months,
- Patient treated in HDF post-dilution,
- Vascular access functioning properly (Qb > 250 ml/min),
- Patient aged 18 years or more,
Key exclusion criteria (7 listed)
- Patient with pre-dialytic albuminemia <3.3 g/dl(Nephelometry assay)
- Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II);
- Patient under guardianship;
- Women pregnant or breast feeding;
- Patient included in other studies that could interfere with the goals of the current study.
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 |
|---|---|---|
| Evodial | Device | Evodial |
| Evodial+ Condition B1 | Device | Evodial+ Condition B1 |
| Evodial+ Condition B2 | Device | Evodial+ Condition B2 |
| Evodial+ Condition C | Device | Evodial+ Condition C |
Primary outcome
Efficacy: Beta 2 Microglobulin elimination
Time frame: Change from T0 (dialysis start) at T4 hours (dialysis stop)
6 secondary outcomes
Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D
Time frame: Change from T0 (dialysis start) at T 4hours (dialysis stop)
Efficacy:Profile of ultrafiltrated proteins
Time frame: at T4 hours
Safety: Follow-up of all AEs/SAEs
Time frame: during the study period
Safety: Measurement of Albumin loss
Time frame: At T4 hours
Efficacy: Cumulative Purified volume (Kt)
Time frame: At T4 hours
Safety: Total protein
Time frame: Change from T0 and T4 hours
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 13 Mar 2025.
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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.
Nathalie Loughraieb study director
Gambro Industries
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evodial, Evodial+ Condition B1 and Evodial+ Condition B2 in people with End Stage Renal Disease (ESRD), run by Vantive Health LLC 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 6 inclusion and 7 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 13 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Efficacy: Beta 2 Microglobulin elimination (time frame: Change from T0 (dialysis start) at T4 hours (dialysis stop)). 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 13 Mar 2025.