Influence of the Vitamine E Coated Dialyzer on Inflammation and Anemia

NCT03218865 | Completed DMC

• 1 other identifier: EVIA 2012-A01502-41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Conditions

End Stage Renal Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inflammatory markers

  one year with a follow-up of three months

• Anemia parameters

  one year with a follow-up of three months

• Nutritional Parameters

  one year with a follow-up of three months

Study Arms (2)

ViE High flux dialyzer

EXPERIMENTAL

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

Leoceed H high flux dialyzer

ACTIVE COMPARATOR

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

Interventions

VIE high flux dialyzer DEVICE

Asssesment of the therapeutic effect of the vitamin E coating

ViE High flux dialyzer

Leoceed H high flux dialyzer DEVICE

Use of the Leoceed H dialyzer during one year per patient enrolled in the control group

Leoceed H high flux dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hemotech: lead

Study Sites (1)

AIDER

Montpellier, Occitanie, 34295, France

Location

Related 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-Jun;26(3):556-63. doi: 10.5301/jn.5000195. Epub 2012 Sep 4.

  PMID: 22956433 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Paul CRISTOL, Doctor

  AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective multicenter controlled and randomized protocol study

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 17, 2017
• Study Start: October 16, 2013
• Primary Completion: June 24, 2018
• Study Completion: December 24, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)