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

NCT ID: NCT03416192

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Chronic Kidney Diseases Uremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCO-HD

Hemodialysis with Medium Cut-Off filter

Group Type EXPERIMENTAL

MCO-HD

Intervention Type DEVICE

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

high-flux HDF

Intervention Type DEVICE

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

High-flux HDF

Hemodiafiltration with standard high-flux filter

Group Type ACTIVE_COMPARATOR

MCO-HD

Intervention Type DEVICE

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

high-flux HDF

Intervention Type DEVICE

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

Interventions

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MCO-HD

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

Intervention Type DEVICE

high-flux HDF

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Christensson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skane, Lund University

Other Identifiers

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2017/830/2

Identifier Type: -

Identifier Source: org_study_id

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