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

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)

Study Overview

• Status: Completed
• Conditions: Inflammation; End Stage Renal Disease
• Intervention / Treatment: Device: VIE high flux dialyzer; Device: Leoceed H high flux dialyzer

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • AIDER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: VIE high flux dialyzer; Asssesment of the therapeutic effect of the vitamin E coating
Active Comparator: 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	Device: Leoceed H high flux dialyzer; Use of the Leoceed H dialyzer during one year per patient enrolled in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the well-known inflammatory marker : High sensibility-CRP	Decrease of the CRP marker due the use of vitamin E coated dialyzer	one year with a follow-up of three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	Evolution of the following inflammatory markers : IL-6, TNFalpha, fibrinogen, antibodies anti-LDLox	one year with a follow-up of three months
Anemia parameters	Evolution of Hemoglobin and ERI	one year with a follow-up of three months
Nutritional Parameters	Albumin and pre-albumin parameters	one year with a follow-up of three months

Collaborators and Investigators

• Sponsor: Hemotech
• Investigators: Study Director: Jean Paul CRISTOL, Doctor, AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2013
• Primary Completion (Actual): June 24, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Inflammation; Kidney Failure, Chronic
• Other Study ID Numbers: EVIA 2012-A01502-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No