ESRDNutriPEPA2NCT04185571
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
A study testing PEPA in people with ESRD, run by Theradial at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- PEPA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 12 Jul 2011to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
12 sites in 2 countries.
Christophe Robino, Doctor contact
12 sites in 2 countries
France11 sites, 11 recruiting
- Recruiting
Ch Annonay
Annonay, 07103
Vincent BISSACCIA, Doctor
Carole DEPRELE, Doctor
- Recruiting
Ch Besancon
Besançon, 25030
Maria YANNARAKI, Doctor
- Recruiting
Ch Chartres
Chartres, 28018
Catherine ALBERT, Doctor
Nabila GOUMRI, Doctor
- Recruiting
Ch La Rochelle
La Rochelle, 17019
Francois POURREAU, Doctor
- Recruiting
CH MEAUX
Meaux, 77104
Hala MOURAM, Doctor
Ibrahim FARAH, Doctor
- Recruiting
Ch Metz-Thionville
Metz, 57085
Zead TUBAIL, Doctor
- Recruiting
Aura Paris Plaisance
Paris, 75014
Pascal SERIS, Doctor
Maeva CLERTE, Doctor
- Recruiting
CH Saint Brieuc
Saint-Brieuc, 22027
Rehouni BOULAHROUZ, Doctor
Caroline FREGUIN, Doctor
- Recruiting
CH Saint Quentin
Saint-Quentin, 02321
Mahen AL BADAWY, Doctor
- Recruiting
Ch Toulouse Larrey
Toulouse, 31400
Arnaud DEL BELLO, Doctor
Ines FERRANDIZ, Doctor
- Recruiting
Chru Tours
Tours, 37044
Maud FRANCOIS, Doctor
Monaco1 site, 1 recruiting
- Recruiting
CHPM Monaco
Monaco, MC, 98014
Manuela DAVIN, Doctor
Christophe Robino, Doctor
About this study
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.
Read the 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
- ESRD
- Being tested
- PEPA
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPADevice
| Study group | Role | What they receive |
|---|---|---|
| PEPA membrane | Experimental | PEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate) Receives: Device: PEPA |
| non adsorbent membrane | No intervention | Comparison with non adsorbent membrane used in routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Possible decrease mortality in patients arm treated with PEPA membrane
Superiority of mortality with other non-adsorbent membrane versus adsorbent
Measured: one year
Secondary outcomes (1)
Evolution of adipocytokines concentration
Evolution of four types of adipocytokines (ghrelin, leptin, adiponectin, resistin)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start12 Jul 2011
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, prospective, multicenter trial, in two parallel arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theradial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BERNARD HORY, Doctor, Principal investigator, Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185571
- Sponsor's protocol ID
- THE2010-01
- Acronym
- NutriPEPA2
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT04185571
- Acronym / sponsor ID
- NutriPEPA2 / THE2010-01
- Conditions
- ESRD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- TheradialIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2011 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, prospective, multicenter trial, in two parallel arms
| Arm | Type | Receives |
|---|---|---|
| PEPA membrane | Experimental | Device: PEPAPEPA membrane is an adsorbant synthetic copolymer (Poly Ester Poly Arylate) |
| non adsorbent membrane | No intervention | –Comparison with non adsorbent membrane used in routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPA | Device | PEPA membrane |
Primary outcome
Possible decrease mortality in patients arm treated with PEPA membrane
Time frame: one year
Superiority of mortality with other non-adsorbent membrane versus adsorbent
1 secondary outcome
Evolution of adipocytokines concentration
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Robino, Doctor contact
BERNARD HORY, Doctor principal investigator
Centre de Néphrologie, 4 ter rue de la Forêt, Avignon, FRANCE
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPA in people with ESRD, run by Theradial at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BERNARD HORY, Doctor (+33 2 28072900, horybernard@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Possible decrease mortality in patients arm treated with PEPA membrane (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.