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

Theradial106 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

106

Conditions

ESRD

Interventions

PEPADEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with Chronic Renal Insufficiency Stage 5, treated by fistula or permanent catheters, * Medium albumin (on 3 recent assays) of less than 35 g / l (this assay being carried out 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 3 months on a non-adsorbing synthetic membrane (of the Polysulfone, Polyethersulfone, PolyArylethersulfone type) of surface at least equal to that of the PEPA dialyser Exclusion Criteria: * Patients allergic to PEPA, * Patients with insufficient vascular access, * Patients with digestive syndromes: Hepatopathy, gastrointestinal amyloidosis, chronic diarrhea, myeloma and dysglobulinaemia, neoplasia and hematopathy, a serious illness that is life-threatening in the short term,

Locations (12)

Ch Annonay

Annonay, France

RECRUITING

Ch Besancon

Besançon, France

RECRUITING

Ch Chartres

Outcomes

Primary Outcomes

Possible decrease mortality in patients arm treated with PEPA membrane

Superiority of mortality with other non-adsorbent membrane versus adsorbent

Time frame: one year

Secondary Outcomes

Evolution of adipocytokines concentration

Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin)

Time frame: one year

Central Contacts

BERNARD HORY, Doctor

CONTACT

+33 2 28072900 horybernard@ymail.com

Christophe Robino, Doctor

CONTACT

Data from ClinicalTrials.gov

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