NCT04185571

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2011

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

9.7 years

First QC Date

November 26, 2019

Last Update Submit

December 3, 2019

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

  • Possible decrease mortality in patients arm treated with PEPA membrane

    Superiority of mortality with other non-adsorbent membrane versus adsorbent

    one year

Secondary Outcomes (1)

  • Evolution of adipocytokines concentration

    one year

Study Arms (2)

PEPA membrane

EXPERIMENTAL

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

Device: PEPA

non adsorbent membrane

NO INTERVENTION

Comparison with non adsorbent membrane used in routine

Interventions

PEPADEVICE
PEPA membrane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Ch Annonay

Annonay, 07103, France

RECRUITING

Ch Besancon

Besançon, 25030, France

RECRUITING

Ch Chartres

Chartres, 28018, France

RECRUITING

Ch La Rochelle

La Rochelle, 17019, France

RECRUITING

CH MEAUX

Meaux, 77104, France

RECRUITING

Ch Metz-Thionville

Metz, 57085, France

RECRUITING

Aura Paris Plaisance

Paris, 75014, France

RECRUITING

CH Saint Brieuc

Saint-Brieuc, 22027, France

RECRUITING

CH Saint Quentin

Saint-Quentin, 02321, France

RECRUITING

Ch Toulouse Larrey

Toulouse, 31400, France

RECRUITING

Chru Tours

Tours, 37044, France

RECRUITING

CHPM Monaco

Monaco, MC, 98014, Monaco

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • BERNARD HORY, Doctor

    Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BERNARD HORY, Doctor

CONTACT

+33 2 28072900horybernard@ymail.com

Christophe Robino, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single-blind, prospective, multicenter trial, in two parallel arms
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 4, 2019

Study Start

July 12, 2011

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)MO(1)