Clinical trial NCT03218865: Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia
Official title: Evaluation of the Dialyzer Vitamin E Coated Effect Inflammatory State of Patients in ESRD and Its Clinical Benefits in Terms of Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Inflammation
Lead sponsor: Hemotech
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective multicenter controlled and randomized protocol study
Primary purpose: TREATMENT

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* 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.

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,

* Patients having received an 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

Primary outcomes:
measure: Evolution of the well-known inflammatory marker : High sensibility-CRP
timeFrame: one year with a follow-up of three months
Secondary outcomes:
measure: Inflammatory markers
timeFrame: one year with a follow-up of three months
measure: Anemia parameters
timeFrame: one year with a follow-up of three months
measure: Nutritional Parameters
timeFrame: one year with a follow-up of three months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: AIDER
state: Occitanie
Study officials:
affiliation: AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5
name: Jean Paul CRISTOL, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.