Clinical trial NCT04185571: Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Official title: Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ESRD
Lead sponsor: Theradial
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Primary purpose: TREATMENT

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).

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,

Primary outcomes:
measure: Possible decrease mortality in patients arm treated with PEPA membrane
timeFrame: one year
Secondary outcomes:
measure: Evolution of adipocytokines concentration
timeFrame: one year
Other outcomes:
Locations:
city: Annonay
country: France
facility: Ch Annonay
city: Besançon
country: France
facility: Ch Besancon
city: Chartres
country: France
facility: Ch Chartres
city: La Rochelle
country: France
facility: Ch La Rochelle
city: Meaux
country: France
facility: CH MEAUX
city: Metz
country: France
facility: Ch Metz-Thionville
city: Paris
country: France
facility: Aura Paris Plaisance
city: Saint-Brieuc
country: France
facility: CH Saint Brieuc
city: Saint-Quentin
country: France
facility: CH Saint Quentin
city: Toulouse
country: France
facility: Ch Toulouse Larrey
city: Tours
country: France
facility: Chru Tours
city: Monaco
country: Monaco
facility: CHPM Monaco
state: MC
Study officials:
affiliation: Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE
name: BERNARD HORY, Doctor
role: PRINCIPAL_INVESTIGATOR
References: