Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Inflammation

• Registration Number: NCT03218865
• Lead Sponsor: Hemotech

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

Study Timeline

• Study Start: 2013-10-16
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-17
• Primary Completion: 2018-06-24
• Study Completion: 2018-12-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AIDER; 🇫🇷 Montpellier, Occitanie, France