Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis (NutriPEPA2)

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.

Study Overview

• Status: Unknown
• Conditions: ESRD
• Intervention / Treatment: Device: PEPA

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annonay, France, 07103
    • Recruiting
    • Ch Annonay
    • Contact: Vincent BISSACCIA, Doctor
    • Contact: Carole DEPRELE, Doctor
    • Principal Investigator: Eric LEGRAND, Doctor
    • Principal Investigator: Jean-Michel MARC, Doctor
  • Besançon, France, 25030
    • Recruiting
    • CH Besancon
    • Contact: Maria YANNARAKI, Doctor
  • Chartres, France, 28018
    • Recruiting
    • CH Chartres
    • Contact: Catherine ALBERT, Doctor
    • Contact: Nabila GOUMRI, Doctor
  • La Rochelle, France, 17019
    • Recruiting
    • CH La Rochelle
    • Contact: Francois POURREAU, Doctor
  • Meaux, France, 77104
    • Recruiting
    • CH Meaux
    • Contact: Hala MOURAM, Doctor
    • Contact: Ibrahim FARAH, Doctor
  • Metz, France, 57085
    • Recruiting
    • Ch Metz-Thionville
    • Contact: Zead TUBAIL, Doctor
  • Paris, France, 75014
    • Recruiting
    • AURA Paris Plaisance
    • Contact: Pascal SERIS, Doctor
    • Contact: Maeva CLERTE, Doctor
  • Saint-Brieuc, France, 22027
    • Recruiting
    • CH Saint Brieuc
    • Contact: Rehouni BOULAHROUZ, Doctor
    • Contact: Caroline FREGUIN, Doctor
  • Saint-Quentin, France, 02321
    • Recruiting
    • CH Saint Quentin
    • Contact: Mahen AL BADAWY, Doctor
  • Toulouse, France, 31400
    • Recruiting
    • Ch Toulouse Larrey
    • Contact: Arnaud DEL BELLO, Doctor
    • Contact: Ines FERRANDIZ, Doctor
  • Tours, France, 37044
    • Recruiting
    • CHRU Tours
    • Contact: Maud FRANCOIS, Doctor
• Monaco
  • MC
    • Monaco, MC, Monaco, 98014
      • Recruiting
      • CHPM Monaco
      • Contact: Christophe Robino, Doctor
      • Contact: Manuela DAVIN, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Theradial
• Investigators: Principal Investigator: BERNARD HORY, Doctor, Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2011
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Inflammation; Malnutrition
• Other Study ID Numbers: THE2010-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No