Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia

Inflammation Clinical Trial

— EVIA  

Official title:

Evaluation of the Dialyzer Vitamin E Coated Effect Inflammatory State of Patients in ESRD and Its Clinical Benefits in Terms of Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218865
• Other study ID #: EVIA 2012-A01502-41
• Status: Completed
• Phase: N/A
• Start date: October 16, 2013
• Est. completion date: December 24, 2018

Study information

• Verified date: February 2019
• Source: Hemotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 patients Prospective multicenter controlled and randomized study Number of patients : 120 patients (60 patients per group)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 24, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Intervention

Device:
• VIE high flux dialyzer
Asssesment of the therapeutic effect of the vitamin E coating
• Leoceed H high flux dialyzer
Use of the Leoceed H dialyzer during one year per patient enrolled in the control group

Locations

Country	Name	City	State
France	AIDER	Montpellier	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
Hemotech

Country where clinical trial is conducted

France, 

References & Publications (1)

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-Ju — View Citation

Outcome

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