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

Not Applicable

Withdrawn

• Conditions: Chronic Kidney Diseases; Uremia
• Interventions: Device: MCO-HD; Device: high-flux HDF

• Registration Number: NCT03416192
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-31
• Study Start: 2019-02
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-flux HDF	MCO-HD	Hemodiafiltration with standard high-flux filter
MCO-HD	MCO-HD	Hemodialysis with Medium Cut-Off filter
MCO-HD	high-flux HDF	Hemodialysis with Medium Cut-Off filter
High-flux HDF	high-flux HDF	Hemodiafiltration with standard high-flux filter

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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