End Stage Renal DiseaseEVIANCT03218865
Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia
A study testing VIE high flux dialyzer and Leoceed H high flux dialyzer in people with End Stage Renal Disease and Inflammation, run by Hemotech at 1 site in France.
Trial summary
Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the inflammatory state of patients' end stage renal disease and its clinical benefits in terms of anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Inflammation
- What is being tested?
- VIE high flux dialyzer and Leoceed H high flux dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2013to 24 Dec 2018
- 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
- Adult ESRD patient, whatever the origin, treated by HD, thrice a week for about 4 hours and hemo dynamically well balanced
- Dialyzed patient on synthetic high flux dialyzer for 3 months
- Patient with a vascular access allowing a blood flow rate ≥ 250 ml/min
- Patient with micro inflammation, i.e an average CRP between 5 and 20 mg/L on the two last check-up of CRP
- Patient informed of the study and having signed the inform consent.
Who cannot join
- Underage patient
- Subjects who are pregnant or planning to become pregnant during the study
- Patient with an infection influencing the Hb level
- Patient with an Iron deficiency showed with :
- Transferin saturation < 20 % and/or Ferritin < 100 µg/L,
- Patients having received an Hemo transfusion in the last two months
Show all 9Show fewer
- Patient treated by HF, HDF, biofiltration
- Patient with infectious risks
- Subjects who participated in a clinical study involving dialyzers in the last two months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dialyzer Vitamin E Coated Effect Inflammatory State of Patients in ESRD and Its Clinical Benefits in Terms of Anemia
Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the inflammatory state of patients' end stage renal disease and its clinical benefits in terms of anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Prospective multicenter controlled and randomized study Number of patients : 120 patients (60 patients per group)
Read the detailed description
Coordinator : Pr JP.CRISTOL Montpellier hospital university Rational : The hemodialyzed patients are subject to inflammation due to their pathologies and to the technique. The VIE dialyzer polysulfon coated to vitamin E has been shown to have a favourable action on inflammation and anemia. The investigators want to highlight the influence of vitamine E graft using as controlled dialyzer a similar polysulfon from the same manufacturer without vitamin E.
Medical device : ViE High flux dialyzer -> vitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure Controlled medical device : Leoceed H high flux dialyzer : polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Primary end point : Evolution of the well-known inflammatory marker : High sensibility-CRP Secondary end point : Evolution of the following inflammatory markers : IL-6, TNFa, fibrinogen, antibodies anti- LDLox Evolution of Hemoglobin and ERI Evolution of Nutritional parameters : albumin and pre albumin Study design : Prospective multicenter controlled and randomized protocol study Duration : 12 months Number of patients : 120 patients : 60 patients per group 120 patients : 60 patients per group Adult ESRD patient, whatever the origin, treated by HD, thrice a week for about 4 hours and hemo dynamically well balanced Inclusion criteria : Dialyzed patient on synthetic high flux dialyzer for 3 months Patient with a vascular access allowing a blood flow rate ≥ 250 ml/min Patient with micro inflammation, i.e an average CRP between 5 and 20 mg/L on the two last check-up of CRP Patient informed of the study and having signed the inform consent. Exclusion criteria : Underage patient Subjects who are pregnant or planning to become pregnant during the study Patient with an infection influencing the Hb level
Patient with an Iron deficiency showed with :
Transferin saturation < 20 % and/or Ferritin < 100 µg/L, Hemo transfusion in the last two months Patient treated by HF, HDF, biofiltration Patient with infectious risks Subjects who participated in a clinical study involving dialyzers in the last two months
Criteria of exit :
Patient wish Medical decision Hemo transfusion Departure for another dialysis center Transplantation Death
- Conditions
- End Stage Renal Disease, Inflammation
- Being tested
- VIE high flux dialyzer, Leoceed H high flux dialyzer
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIE high flux dialyzerDevice
Asssesment of the therapeutic effect of the vitamin E coating
Leoceed H high flux dialyzerDevice
Use of the Leoceed H dialyzer during one year per patient enrolled in the control group
| Study group | Role | What they receive |
|---|---|---|
| ViE High flux dialyzer | Experimental | vitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure Receives: Device: VIE high flux dialyzer |
| Leoceed H high flux dialyzer | Active comparator | polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure Receives: Device: Leoceed H high flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the well-known inflammatory marker : High sensibility-CRP
Decrease of the CRP marker due the use of vitamin E coated dialyzer
Measured: one year with a follow-up of three months
Secondary outcomes (3)
Inflammatory markers
Evolution of the following inflammatory markers : IL-6, TNFalpha, fibrinogen, antibodies anti-LDLox
Measured: one year with a follow-up of three months
Anemia parameters
Evolution of Hemoglobin and ERI
Measured: one year with a follow-up of three months
Nutritional Parameters
Albumin and pre-albumin parameters
Measured: one year with a follow-up of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start16 Oct 2013
- Primary completion24 Jun 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal 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
- Model description
- Prospective multicenter controlled and randomized protocol study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Paul CRISTOL, Doctor, Study director, AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218865
- Sponsor's protocol ID
- EVIA 2012-A01502-41
- Acronym
- EVIA
- Status last verified
- Feb 2019
- First submitted
- 4 Jul 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bargnoux AS, Cristol JP, Jaussent I, Chalabi L, Bories P, Dion JJ, Henri P, Delage M, Dupuy AM, Badiou S, Canaud B, Morena M. Vitamin E-coated polysulfone membrane improved red blood cell antioxidant status in hemodialysis patients. J Nephrol. 2013 May-Jun;26(3):556-63. doi: 10.5301/jn.5000195. Epub 2012 Sep 4.
PubMed 22956433
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dialyzer Vitamin E Coated Effect Inflammatory State of Patients in ESRD and Its Clinical Benefits in Terms of Anemia
- ClinicalTrials.gov ID
- NCT03218865
- Acronym / sponsor ID
- EVIA / EVIA 2012-A01502-41
- Conditions
- End Stage Renal Disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- HemotechIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- 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.
Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the inflammatory state of patients' end stage renal disease and its clinical benefits in terms of anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Prospective multicenter controlled and randomized study Number of patients : 120 patients (60 patients per group)
Detailed description
Coordinator : Pr JP.CRISTOL Montpellier hospital university Rational : The hemodialyzed patients are subject to inflammation due to their pathologies and to the technique. The VIE dialyzer polysulfon coated to vitamin E has been shown to have a favourable action on inflammation and anemia. The investigators want to highlight the influence of vitamine E graft using as controlled dialyzer a similar polysulfon from the same manufacturer without vitamin E.
Medical device : ViE High flux dialyzer -> vitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure Controlled medical device : Leoceed H high flux dialyzer : polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Primary end point : Evolution of the well-known inflammatory marker : High sensibility-CRP Secondary end point : Evolution of the following inflammatory markers : IL-6, TNFa, fibrinogen, antibodies anti- LDLox Evolution of Hemoglobin and ERI Evolution of Nutritional parameters : albumin and pre albumin Study design : Prospective multicenter controlled and randomized protocol study Duration : 12 months Number of patients : 120 patients : 60 patients per group 120 patients : 60 patients per group Adult ESRD patient, whatever the origin, treated by HD, thrice a week for about 4 hours and hemo dynamically well balanced Inclusion criteria : Dialyzed patient on synthetic high flux dialyzer for 3 months Patient with a vascular access allowing a blood flow rate ≥ 250 ml/min Patient with micro inflammation, i.e an average CRP between 5 and 20 mg/L on the two last check-up of CRP Patient informed of the study and having signed the inform consent. Exclusion criteria : Underage patient Subjects who are pregnant or planning to become pregnant during the study Patient with an infection influencing the Hb level
Patient with an Iron deficiency showed with :
Transferin saturation < 20 % and/or Ferritin < 100 µg/L, Hemo transfusion in the last two months Patient treated by HF, HDF, biofiltration Patient with infectious risks Subjects who participated in a clinical study involving dialyzers in the last two months
Criteria of exit :
Patient wish Medical decision Hemo transfusion Departure for another dialysis center Transplantation Death
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multicenter controlled and randomized protocol study
| Arm | Type | Receives |
|---|---|---|
| ViE High flux dialyzer | Experimental | Device: VIE high flux dialyzervitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure |
| Leoceed H high flux dialyzer | Active comparator | Device: Leoceed H high flux dialyzerpolysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ESRD patient, whatever the origin, treated by HD, thrice a week for about 4 hours and hemo dynamically well balanced
- Dialyzed patient on synthetic high flux dialyzer for 3 months
- Patient with a vascular access allowing a blood flow rate ≥ 250 ml/min
- Patient with micro inflammation, i.e an average CRP between 5 and 20 mg/L on the two last check-up of CRP
- Patient informed of the study and having signed the inform consent.
Key exclusion criteria (9 listed)
- Underage patient
- Subjects who are pregnant or planning to become pregnant during the study
- Patient with an infection influencing the Hb level
- Patient with an Iron deficiency showed with :
- Transferin saturation < 20 % and/or Ferritin < 100 µg/L,
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 |
|---|---|---|
| VIE high flux dialyzerAsssesment of the therapeutic effect of the vitamin E coating | Device | ViE High flux dialyzer |
| Leoceed H high flux dialyzerUse of the Leoceed H dialyzer during one year per patient enrolled in the control group | Device | Leoceed H high flux dialyzer |
Primary outcome
Evolution of the well-known inflammatory marker : High sensibility-CRP
Time frame: one year with a follow-up of three months
Decrease of the CRP marker due the use of vitamin E coated dialyzer
3 secondary outcomes
Inflammatory markers
Time frame: one year with a follow-up of three months
Anemia parameters
Time frame: one year with a follow-up of three months
Nutritional Parameters
Time frame: one year with a follow-up of three months
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 Feb 2019.
- Results publication: PubMed 22956433Bargnoux AS, Cristol JP, Jaussent I, Chalabi L, Bories P, Dion JJ, Henri P, Delage M, Dupuy AM, Badiou S, Canaud B, Morena M. Vitamin E-coated polysulfone membrane improved red blood cell antioxidant status in hemodialysis patients. J Nephrol. 2013 May-Jun;26(3):556-63. doi: 10.5301/jn.5000195. Epub 2012 Sep 4.
- Individual participant dataSharing planned: No
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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.
Jean Paul CRISTOL, Doctor study director
AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIE high flux dialyzer and Leoceed H high flux dialyzer in people with End Stage Renal Disease and Inflammation, run by Hemotech 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 5 inclusion and 9 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 Feb 2019. 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?
Evolution of the well-known inflammatory marker : High sensibility-CRP (time frame: one year with a follow-up of three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218865, which also lists 1 linked publication.
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 Feb 2019.