Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia (EVIA)

Hemotech

Status: Completed

Conditions: Inflammation; End Stage Renal Disease

Treatments: Device: VIE high flux dialyzer; Device: Leoceed H high flux dialyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218865

EVIA 2012-A01502-41

Details and patient eligibility

About

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)

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

ViE High flux dialyzer

Experimental group

Description:

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

Treatment:

Device: VIE high flux dialyzer

Leoceed H high flux dialyzer

Active Comparator group

Description:

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

Treatment:

Device: Leoceed H high flux dialyzer