12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03416192

Enrollment

Registered

2018-01-31

Start date

2019-02-28

Completion date

2019-12-31

Last updated

2020-04-15

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

Conditions

Chronic Kidney Diseases, Uremia

Keywords

Dialysis, MCO, Middle molecules

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 aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.

Interventions

DEVICEMCO-HD

Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.

DEVICEhigh-flux HDF

Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter

Study design

Allocation

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 (\>3 months) * Oliguric * Albumin ≥ 30 * CRP \<15 * No acute myocardial infarction within 3 months. * Swedish or english speaking.

Exclusion criteria

\- Not able to understand the study information.

Design outcomes

Primary

Measure	Time frame
Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).	12 weeks
Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).	12 weeks

Secondary

Measure	Time frame
Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).	12 weeks
Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).	12 weeks
Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.	12 weeks
Comparison of number of adverse effects during the study period.	12 weeks
Comparison of mean nPCR after 12 weeks.	12 weeks
Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.	8 weeks
Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.	12 weeks

Outcome results

None listed

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