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

Sponsor
Theradial (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04185571
Collaborator
(none)
106
Enrollment
12
Locations
2
Arms
124.7
Anticipated Duration (Months)
8.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: PEPA
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, single-blind, prospective, multicenter trial, in two parallel armsRandomized, single-blind, prospective, multicenter trial, in two parallel arms
Masking:
Single (Participant)
Masking Description:
Patients will be randomized and included in one of the following 2 groups group 1: PEPA membrane / group 2: non-adsorbent synthetic membrane . The randomization will be stratified on the center
Primary Purpose:
Treatment
Official Title:
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Actual Study Start Date :
Jul 12, 2011
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Possible decrease mortality in patients arm treated with PEPA membrane [one year]

    Superiority of mortality with other non-adsorbent membrane versus adsorbent

Secondary Outcome Measures

  1. Evolution of adipocytokines concentration [one year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ch Annonay Annonay France 07103
2 Ch Besancon Besançon France 25030
3 Ch Chartres Chartres France 28018
4 Ch La Rochelle La Rochelle France 17019
5 CH MEAUX Meaux France 77104
6 Ch Metz-Thionville Metz France 57085
7 Aura Paris Plaisance Paris France 75014
8 CH Saint Brieuc Saint-Brieuc France 22027
9 CH Saint Quentin Saint-Quentin France 02321
10 Ch Toulouse Larrey Toulouse France 31400
11 Chru Tours Tours France 37044
12 CHPM Monaco Monaco MC Monaco 98014

Sponsors and Collaborators

  • Theradial

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theradial
ClinicalTrials.gov Identifier:
NCT04185571
Other Study ID Numbers:
  • THE2010-01
First Posted:
Dec 4, 2019
Last Update Posted:
Dec 4, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Malnutrition
Inflammation

Study Results

No Results Posted as of Dec 4, 2019