End Stage Renal Disease (ESRD)EMCOPEWNCT05309109
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study
A study testing Hemodialysis sessions in people with End Stage Renal Disease (ESRD), run by Poitiers University Hospital at 2 sites in France.
Trial summary
In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Hemodialysis sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Sep 2022to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients able to give signed informed consent
- Age ≥ 18 years
- Patients established on HF-HD trice weekly four hour-sessions for at least 3 months.
- Patients able to walk
- Body mass index ≥ 20 and < 40 Kg/m2
Who cannot join
- Any uncontrolled medical condition, psychiatric disorder or biological abnormality that might interfere with subject's participation or ability to sign an informed consent.
- Implanted pace maker or cardioverter defibrillator
- Pregnant or breast-feeding women
- Active malignant disease, chronic inflammatory disease or other critical illnesses that may interfere with inflammatory parameters. Baseline C-reactive protein > 35 mg/l.
- Amputated limbs
- Prescription of oral or intra venous nutrition supplements
- Significant residual kidney function as defined by an urine output > 500 mL
- Patients allergic to polyethersulfone membranes
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Poitiers
Poitiers, 86000
AURA Poitou-Charentes
Saint-Benoît, 86281
About this study
Official title: Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting
In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality. Several factors, including inflammation, oxidative stress, metabolic disorders, loss of nutrients, diabetes, retention of middle molecule uremic toxins and dialysis procedure contribute to PEW. It has been previously reported that intensive HD treatments such as short daily and nocturnal HD may improve nutritional parameters. Moreover, post-dilution Online hemodiafiltration (OL-HDF) may also improve PEW by preserving lean body mass evaluated by bioimpedance analysis (BIA) probably through decreased inflammation, stimulation of appetite and better removal of uremic toxins. The recently developed medium cut-off dialyzer (MCO) in HD has demonstrated efficient depuration of middle uremic toxins as compared to high flux HD (HF-HD), similar to that of OL-HDF. Both MCO-HD and OL-HDF may exert beneficial effects on PEW, since they increase removal of higher weight middle molecules, which mostly encompass proteins related to inflammation and PEW in the uremic milieu
Read the detailed description
In a previous randomized study, we found, that after 3 months, MCO-HD was associated with higher middle molecules removal and significant decrease in beta2-microglobulin, oxidized low-density lipoprotein, kappa and lambda free light chain pre-dialysis levels, without change in other inflammatory and oxidative stress biomarkers. In addition, compared to HF-HD, a modulation of inflammation has been demonstrated with MCO-HD in another randomized trial. After 3 months, MCO-HD was shown to downregulate the expression of the pro-inflammatory IL-6 and tumor necrosis factor (TNF) mRNA in peripheral leucocytes. Moreover, higher removal and decrease in TNF alpha level with concurrent reduced resistance to erythropoiesis stimulating agents (ESA) has been also reported with MCO-HD. However, the long-term effects of MCO-HD on inflammatory, uremic toxins and malnutrition biomarkers remain to be established.
To test the hypothesis that MCO-HD may positively affect body composition and nutritional status in HD patients we performed a 12-month single center retrospective pilot study. Compared to HF-HD, MCO-HD resulted in an improved variation rate of serum pre-dialysis creatinine level, lean tissue, skeletal muscle mass and index assessed by BIA, which are presumably good surrogate markers of PEW.
The aim of the present prospective, controlled randomized study is to evaluate the effect of MCO-HD on PEW, compared to standard HF-HD in chronic hemodialysis patients.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Hemodialysis sessions
- Keywords
- hemodialysis, protein energy wasting, medium cut-off dialyzer, lean mass, bioimpedance
- 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.
Hemodialysis sessionsOther
Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.
| Study group | Role | What they receive |
|---|---|---|
| MCO-HD group | Experimental | Hemodialysis sessions using the Theranova 500™ (Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg) Receives: Other: Hemodialysis sessions |
| HF-HD group | Experimental | Hemodialysis sessions using the Elisio 21H™ (Nipro Europe, Zaventen Belgium; surface area 2.1 m², ultrafiltration coefficient: 82 ml/h/mmHg) Receives: Other: Hemodialysis sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline to the End of the Study in Lean Tissue Mass Measured Using Bioimpedance Analysis Through the Study.
The difference between the lean tissue mass measured at 12 months and the lean tissue mass measured at baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start26 Sep 2022
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309109
- Sponsor's protocol ID
- EMCOPEW
- Acronym
- EMCOPEW
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2022
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting
- ClinicalTrials.gov ID
- NCT05309109
- Acronym / sponsor ID
- EMCOPEW / EMCOPEW
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- hemodialysis, protein energy wasting, medium cut-off dialyzer, lean mass, bioimpedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality. Several factors, including inflammation, oxidative stress, metabolic disorders, loss of nutrients, diabetes, retention of middle molecule uremic toxins and dialysis procedure contribute to PEW. It has been previously reported that intensive HD treatments such as short daily and nocturnal HD may improve nutritional parameters. Moreover, post-dilution Online hemodiafiltration (OL-HDF) may also improve PEW by preserving lean body mass evaluated by bioimpedance analysis (BIA) probably through decreased inflammation, stimulation of appetite and better removal of uremic toxins. The recently developed medium cut-off dialyzer (MCO) in HD has demonstrated efficient depuration of middle uremic toxins as compared to high flux HD (HF-HD), similar to that of OL-HDF. Both MCO-HD and OL-HDF may exert beneficial effects on PEW, since they increase removal of higher weight middle molecules, which mostly encompass proteins related to inflammation and PEW in the uremic milieu
Detailed description
In a previous randomized study, we found, that after 3 months, MCO-HD was associated with higher middle molecules removal and significant decrease in beta2-microglobulin, oxidized low-density lipoprotein, kappa and lambda free light chain pre-dialysis levels, without change in other inflammatory and oxidative stress biomarkers. In addition, compared to HF-HD, a modulation of inflammation has been demonstrated with MCO-HD in another randomized trial. After 3 months, MCO-HD was shown to downregulate the expression of the pro-inflammatory IL-6 and tumor necrosis factor (TNF) mRNA in peripheral leucocytes. Moreover, higher removal and decrease in TNF alpha level with concurrent reduced resistance to erythropoiesis stimulating agents (ESA) has been also reported with MCO-HD. However, the long-term effects of MCO-HD on inflammatory, uremic toxins and malnutrition biomarkers remain to be established.
To test the hypothesis that MCO-HD may positively affect body composition and nutritional status in HD patients we performed a 12-month single center retrospective pilot study. Compared to HF-HD, MCO-HD resulted in an improved variation rate of serum pre-dialysis creatinine level, lean tissue, skeletal muscle mass and index assessed by BIA, which are presumably good surrogate markers of PEW.
The aim of the present prospective, controlled randomized study is to evaluate the effect of MCO-HD on PEW, compared to standard HF-HD in chronic hemodialysis patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCO-HD group | Experimental | Other: Hemodialysis sessionsHemodialysis sessions using the Theranova 500™ (Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg) |
| HF-HD group | Experimental | Other: Hemodialysis sessionsHemodialysis sessions using the Elisio 21H™ (Nipro Europe, Zaventen Belgium; surface area 2.1 m², ultrafiltration coefficient: 82 ml/h/mmHg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients able to give signed informed consent
- Age ≥ 18 years
- Patients established on HF-HD trice weekly four hour-sessions for at least 3 months.
- Patients able to walk
- Body mass index ≥ 20 and < 40 Kg/m2
Key exclusion criteria (8 listed)
- Any uncontrolled medical condition, psychiatric disorder or biological abnormality that might interfere with subject's participation or ability to sign an informed consent.
- Implanted pace maker or cardioverter defibrillator
- Pregnant or breast-feeding women
- Active malignant disease, chronic inflammatory disease or other critical illnesses that may interfere with inflammatory parameters. Baseline C-reactive protein > 35 mg/l.
- Amputated limbs
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 |
|---|---|---|
| Hemodialysis sessionsPatients will receive thrice weekly 4 hours hemodialysis sessions during 12 months. | Other | HF-HD group, MCO-HD group |
Primary outcome
The Change From Baseline to the End of the Study in Lean Tissue Mass Measured Using Bioimpedance Analysis Through the Study.
Time frame: 12 months
The difference between the lean tissue mass measured at 12 months and the lean tissue mass measured at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis sessions in people with End Stage Renal Disease (ESRD), run by Poitiers University Hospital at 2 sites in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change From Baseline to the End of the Study in Lean Tissue Mass Measured Using Bioimpedance Analysis Through the Study. (time frame: 12 months). 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 29 Oct 2026.