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

Theradial

Status: Unknown

Conditions: ESRD

Treatments: Device: PEPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185571

THE2010-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

106 participants in 2 patient groups

PEPA membrane

Experimental group

Description:

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

Treatment:

Device: PEPA

non adsorbent membrane

No Intervention group

Description:

Comparison with non adsorbent membrane used in routine