Trials / Unknown
UnknownNCT04185571
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- Sponsor
- Theradial · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PEPA |
Timeline
- Start date
- 2011-07-12
- Primary completion
- 2021-04-01
- Completion
- 2021-12-01
- First posted
- 2019-12-04
- Last updated
- 2019-12-04
Locations
12 sites across 2 countries: France, Monaco
Source: ClinicalTrials.gov record NCT04185571. Inclusion in this directory is not an endorsement.