Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Theradial
- Enrollment
- 106
- Locations
- 12
- Primary Endpoint
- Possible decrease mortality in patients arm treated with PEPA membrane
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Arms & Interventions
PEPA membrane
PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate)
Intervention: PEPA (Device)
non adsorbent membrane
Comparison with non adsorbent membrane used in routine
Outcomes
Primary Outcomes
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 Outcomes
- Evolution of adipocytokines concentration(one year)