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

ESRD Clinical Trial

— NutriPEPA2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185571
• Other study ID #: THE2010-01
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2011
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Theradial
• Contact: BERNARD HORY, Doctor
• Phone: +33 2 28072900
• Email: horybernard[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• ESRD
• Inflammation
• Malnutrition

Intervention

Device:
• PEPA

Locations

Country	Name	City	State
France	Ch Annonay	Annonay
France	Ch Besancon	Besançon
France	Ch Chartres	Chartres
France	Ch La Rochelle	La Rochelle
France	CH MEAUX	Meaux
France	Ch Metz-Thionville	Metz
France	Aura Paris Plaisance	Paris
France	CH Saint Brieuc	Saint-Brieuc
France	CH Saint Quentin	Saint-Quentin
France	Ch Toulouse Larrey	Toulouse
France	Chru Tours	Tours
Monaco	CHPM Monaco	Monaco	MC

Sponsors (1)

Lead Sponsor	Collaborator
Theradial

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possible decrease mortality in patients arm treated with PEPA membrane	Superiority of mortality with other non-adsorbent membrane versus adsorbent	one year
Secondary	Evolution of adipocytokines concentration	Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin)	one year