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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185571
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Theradial

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
ESRD Device: PEPA Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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 : July 12, 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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



Primary Outcome Measures :
  1. Possible decrease mortality in patients arm treated with PEPA membrane [ Time Frame: one year ]
    Superiority of mortality with other non-adsorbent membrane versus adsorbent


Secondary Outcome Measures :
  1. Evolution of adipocytokines concentration [ Time Frame: one year ]
    Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin)



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185571


Contacts
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Contact: BERNARD HORY, Doctor +33 2 28072900 horybernard@ymail.com
Contact: Christophe Robino, Doctor

Locations
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France
Ch Annonay Recruiting
Annonay, France, 07103
Contact: Vincent BISSACCIA, Doctor         
Contact: Carole DEPRELE, Doctor         
Principal Investigator: Eric LEGRAND, Doctor         
Principal Investigator: Jean-Michel MARC, Doctor         
Ch Besancon Recruiting
Besançon, France, 25030
Contact: Maria YANNARAKI, Doctor         
Ch Chartres Recruiting
Chartres, France, 28018
Contact: Catherine ALBERT, Doctor         
Contact: Nabila GOUMRI, Doctor         
Ch La Rochelle Recruiting
La Rochelle, France, 17019
Contact: Francois POURREAU, Doctor         
CH MEAUX Recruiting
Meaux, France, 77104
Contact: Hala MOURAM, Doctor         
Contact: Ibrahim FARAH, Doctor         
Ch Metz-Thionville Recruiting
Metz, France, 57085
Contact: Zead TUBAIL, Doctor         
Aura Paris Plaisance Recruiting
Paris, France, 75014
Contact: Pascal SERIS, Doctor         
Contact: Maeva CLERTE, Doctor         
CH Saint Brieuc Recruiting
Saint-Brieuc, France, 22027
Contact: Rehouni BOULAHROUZ, Doctor         
Contact: Caroline FREGUIN, Doctor         
CH Saint Quentin Recruiting
Saint-Quentin, France, 02321
Contact: Mahen AL BADAWY, Doctor         
Ch Toulouse Larrey Recruiting
Toulouse, France, 31400
Contact: Arnaud DEL BELLO, Doctor         
Contact: Ines FERRANDIZ, Doctor         
Chru Tours Recruiting
Tours, France, 37044
Contact: Maud FRANCOIS, Doctor         
Monaco
CHPM Monaco Recruiting
Monaco, MC, Monaco, 98014
Contact: Manuela DAVIN, Doctor         
Contact: Christophe Robino, Doctor         
Sponsors and Collaborators
Theradial
Investigators
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Principal Investigator: BERNARD HORY, Doctor Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE

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Responsible Party: Theradial
ClinicalTrials.gov Identifier: NCT04185571    
Other Study ID Numbers: THE2010-01
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Inflammation
Pathologic Processes
Nutrition Disorders