Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEPA membrane | Experimental | PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate) |
|
| non adsorbent membrane | No Intervention | Comparison with non adsorbent membrane used in routine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEPA | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Possible decrease mortality in patients arm treated with PEPA membrane | Superiority of mortality with other non-adsorbent membrane versus adsorbent | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of adipocytokines concentration | Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin) | one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BERNARD HORY, Doctor | Contact | +33 2 28072900 | horybernard@ymail.com | |
| Christophe Robino, Doctor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| BERNARD HORY, Doctor | Centre de NĂ©phrologie, 4 ter rue de la ForĂªt, Avignon, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Annonay | Recruiting | Annonay | 07103 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Not provided
Not provided
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
| Ch Besancon | Recruiting | Besançon | 25030 | France |
|
| Ch Chartres | Recruiting | Chartres | 28018 | France |
|
| Ch La Rochelle | Recruiting | La Rochelle | 17019 | France |
|
| CH MEAUX | Recruiting | Meaux | 77104 | France |
|
| Ch Metz-Thionville | Recruiting | Metz | 57085 | France |
|
| Aura Paris Plaisance | Recruiting | Paris | 75014 | France |
|
| CH Saint Brieuc | Recruiting | Saint-Brieuc | 22027 | France |
|
| CH Saint Quentin | Recruiting | Saint-Quentin | 02321 | France |
|
| Ch Toulouse Larrey | Recruiting | Toulouse | 31400 | France |
|
| Chru Tours | Recruiting | Tours | 37044 | France |
|
| CHPM Monaco | Recruiting | Monaco | MC | 98014 | Monaco |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |