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

Sponsor

Region Skane (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03416192

Collaborator

Lund University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Uremia	Device: MCO-HD Device: high-flux HDF	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MCO-HD Hemodialysis with Medium Cut-Off filter	Device: MCO-HD Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter. Device: high-flux HDF Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter
Active Comparator: High-flux HDF Hemodiafiltration with standard high-flux filter	Device: MCO-HD Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter. Device: high-flux HDF Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter

Arm

Intervention/Treatment

Experimental: MCO-HD

Hemodialysis with Medium Cut-Off filter

Device: MCO-HD

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

Device: high-flux HDF

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

Active Comparator: High-flux HDF

Hemodiafiltration with standard high-flux filter

Device: MCO-HD

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

Device: high-flux HDF

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

Outcome Measures

Primary Outcome Measures

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

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 postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG). [12 weeks]
Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks. [8 weeks]
Comparison of number of adverse effects during the study period. [12 weeks]
Comparison of mean nPCR after 12 weeks. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Region Skane
Lund University

Investigators

Principal Investigator: Anders Christensson, MD, PhD, Region Skane, Lund University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Region Skane

ClinicalTrials.gov Identifier:

NCT03416192

Other Study ID Numbers:

2017/830/2

First Posted:

Jan 31, 2018

Last Update Posted:

Apr 15, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Region Skane

Dialysis

MCO

Middle molecules

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Apr 15, 2020