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

Primary Purpose

ESRD

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PEPA
Sponsored by
Theradial
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Ch AnnonayRecruiting
  • Ch BesanconRecruiting
  • Ch ChartresRecruiting
  • Ch La RochelleRecruiting
  • CH MEAUXRecruiting
  • Ch Metz-ThionvilleRecruiting
  • Aura Paris PlaisanceRecruiting
  • CH Saint BrieucRecruiting
  • CH Saint QuentinRecruiting
  • Ch Toulouse LarreyRecruiting
  • Chru ToursRecruiting
  • CHPM MonacoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEPA membrane

non adsorbent membrane

Arm Description

PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate)

Comparison with non adsorbent membrane used in routine

Outcomes

Primary Outcome Measures

Possible decrease mortality in patients arm treated with PEPA membrane
Superiority of mortality with other non-adsorbent membrane versus adsorbent

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2019
Last Updated
December 3, 2019
Sponsor
Theradial
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1. Study Identification

Unique Protocol Identification Number
NCT04185571
Brief Title
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Acronym
NutriPEPA2
Official Title
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2011 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theradial

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Masking
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
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEPA membrane
Arm Type
Experimental
Arm Description
PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate)
Arm Title
non adsorbent membrane
Arm Type
No Intervention
Arm Description
Comparison with non adsorbent membrane used in routine
Intervention Type
Device
Intervention Name(s)
PEPA
Primary Outcome Measure Information:
Title
Possible decrease mortality in patients arm treated with PEPA membrane
Description
Superiority of mortality with other non-adsorbent membrane versus adsorbent
Time Frame
one year
Secondary Outcome Measure Information:
Title
Evolution of adipocytokines concentration
Description
Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BERNARD HORY, Doctor
Phone
+33 2 28072900
Email
horybernard@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Robino, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD HORY, Doctor
Organizational Affiliation
Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Annonay
City
Annonay
ZIP/Postal Code
07103
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BISSACCIA, Doctor
First Name & Middle Initial & Last Name & Degree
Carole DEPRELE, Doctor
First Name & Middle Initial & Last Name & Degree
Eric LEGRAND, Doctor
First Name & Middle Initial & Last Name & Degree
Jean-Michel MARC, Doctor
Facility Name
Ch Besancon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria YANNARAKI, Doctor
Facility Name
Ch Chartres
City
Chartres
ZIP/Postal Code
28018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine ALBERT, Doctor
First Name & Middle Initial & Last Name & Degree
Nabila GOUMRI, Doctor
Facility Name
Ch La Rochelle
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois POURREAU, Doctor
Facility Name
CH MEAUX
City
Meaux
ZIP/Postal Code
77104
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala MOURAM, Doctor
First Name & Middle Initial & Last Name & Degree
Ibrahim FARAH, Doctor
Facility Name
Ch Metz-Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zead TUBAIL, Doctor
Facility Name
Aura Paris Plaisance
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal SERIS, Doctor
First Name & Middle Initial & Last Name & Degree
Maeva CLERTE, Doctor
Facility Name
CH Saint Brieuc
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehouni BOULAHROUZ, Doctor
First Name & Middle Initial & Last Name & Degree
Caroline FREGUIN, Doctor
Facility Name
CH Saint Quentin
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahen AL BADAWY, Doctor
Facility Name
Ch Toulouse Larrey
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud DEL BELLO, Doctor
First Name & Middle Initial & Last Name & Degree
Ines FERRANDIZ, Doctor
Facility Name
Chru Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud FRANCOIS, Doctor
Facility Name
CHPM Monaco
City
Monaco
State/Province
MC
ZIP/Postal Code
98014
Country
Monaco
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela DAVIN, Doctor
First Name & Middle Initial & Last Name & Degree
Christophe Robino, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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

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