Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study

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

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers, Poitiers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hemodialysis sessions

Other

Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

Baxter Healthcare Corporation

Registry information

Official study title

Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting

Acronym: EMCOPEW

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Apr 4, 2022
Registry last updated: Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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