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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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ESRD

Intervention / Treatment
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* Device: PEPA


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEPA membrane<br>PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate) | Device: PEPA<br> <br> |
| No Intervention: non adsorbent membrane<br>Comparison with non adsorbent membrane used in routine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possible decrease mortality in patients arm treated with PEPA membrane | Superiority of mortality with other non-adsorbent membrane versus adsorbent | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of adipocytokines concentration | Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin) | one year |