Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03437538

Enrollment

Registered

2018-02-19

Start date

2018-05-21

Completion date

2019-04-16

Last updated

2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Dialysis, Uremia

Keywords

Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off

Brief summary

The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters. The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter. Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.

Interventions

DEVICEMCO-HD

Measurements will be done during a single hemodialysis session with Medium Cut-Off filter

DEVICEHigh-flux HDF

Measurements will be done during a single hemodiafiltration session with standard high-flux filter

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Ongoing HDF treatment * CRP \<30 * No Acute Myocardial Infarction within 3 months.

Exclusion criteria

* Not able to understand the study information.

Design outcomes

Primary

Measure	Time frame	Description
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	30 minutes	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

Secondary

Measure	Time frame	Description
Number of Adverse Events	4 hours	Number of adverse events during a 4h dialysis session
RR of large molecules (Albumin, Transferrin, IgG)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	30 minutes	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	30 minutes	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
RR of small molecules (Urea, Phosphate, Creatinine)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026