ESRD
Conditions
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).
Interventions
DEVICEPEPA
Sponsors
Theradial
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Intervention model description
Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Possible decrease mortality in patients arm treated with PEPA membrane | one year | Superiority of mortality with other non-adsorbent membrane versus adsorbent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of adipocytokines concentration | one year | Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin) |
Countries
France, Monaco
Contacts
Primary ContactBERNARD HORY, Doctor
Backup ContactChristophe Robino, Doctor
Outcome results
None listed