Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Inflammation
• Interventions: Device: VIE high flux dialyzer; Device: Leoceed H high flux dialyzer

• 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

Arm && Interventions

Group	Intervention	Description
ViE High flux dialyzer	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
Leoceed H high flux dialyzer	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

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