Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

Last updated: December 3, 2019
Sponsor: Theradial
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Weight Loss

Diet And Nutrition

Treatment

N/A

Clinical Study ID

NCT04185571
THE2010-01
  • Ages > 18
  • All Genders

Study Summary

NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with Chronic Renal Insufficiency Stage 5, treated by fistula or permanentcatheters,

  • Medium albumin (on 3 recent assays) of less than 35 g / l (this assay being carriedout by a non-electrophoretic technique),

  • PINI score greater than or equal to 1,

  • Beginning of the treatment of extra-renal purification by hemodialysis for at least 3months on a non-adsorbing synthetic membrane (of the Polysulfone, Polyethersulfone,PolyArylethersulfone type) of surface at least equal to that of the PEPA dialyser

Exclusion

Exclusion Criteria:

  • Patients allergic to PEPA,

  • Patients with insufficient vascular access,

  • Patients with digestive syndromes: Hepatopathy, gastrointestinal amyloidosis, chronicdiarrhea, myeloma and dysglobulinaemia, neoplasia and hematopathy, a serious illnessthat is life-threatening in the short term,

Study Design

Total Participants: 106
Study Start date:
July 12, 2011
Estimated Completion Date:
December 31, 2021

Study Description

The objective of NutriPEPA2 study is to demonstrate that the use of an adsorbent membrane (PEPA-Poly Ester Poly Arylate synthetic co-polymer membrane) decreases undernutrition (often associated with inflammation) and consequently morbidity, comparing one year mortality in patients with Chronic Kidney Disease (CKD), with severe Protein-Energy Wasting (PEW), treated with dialysis using a non-adsorbent synthetic membrane (Polysulfone or Polyethersulfone) versus an adsorbent membrane (PEPA).

Connect with a study center

  • Ch Annonay

    Annonay, 07103
    France

    Active - Recruiting

  • Ch Besancon

    Besançon, 25030
    France

    Active - Recruiting

  • Ch Chartres

    Chartres, 28018
    France

    Active - Recruiting

  • Ch La Rochelle

    La Rochelle, 17019
    France

    Active - Recruiting

  • CH MEAUX

    Meaux, 77104
    France

    Active - Recruiting

  • Ch Metz-Thionville

    Metz, 57085
    France

    Active - Recruiting

  • Aura Paris Plaisance

    Paris, 75014
    France

    Active - Recruiting

  • CH Saint Brieuc

    Saint-Brieuc, 22027
    France

    Active - Recruiting

  • CH Saint Quentin

    Saint-Quentin, 02321
    France

    Active - Recruiting

  • Ch Toulouse Larrey

    Toulouse, 31400
    France

    Active - Recruiting

  • Chru Tours

    Tours, 37044
    France

    Active - Recruiting

  • CHPM Monaco

    Monaco, MC 98014
    Monaco

    Active - Recruiting

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