NCT05309109Completed
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 26 Sept 2022
- Primary completion date
- 27 Mar 2025
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT05309109
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From 26 Sept 2022 to the primary completion date, 27 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any uncontrolled medical condition, psychiatric disorder or biological abnormality that might interfere with subject's participation or ability to sign an informed consent.
- Active malignant disease, chronic inflammatory disease or other critical illnesses that may interfere with inflammatory parameters. Baseline C-reactive protein \> 35 mg/l.
- Patients allergic to polyethersulfone membranes
Other
- Implanted pace maker or cardioverter defibrillator
- Pregnant or breast-feeding women
- Amputated limbs
- Prescription of oral or intra venous nutrition supplements
- Significant residual kidney function as defined by an urine output \> 500 mL
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| AURA Poitou-Charentes Coordinator of this site? Confirm its status | Saint-Benoît | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.