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

April 14, 2020 updated by: Region Skane

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Lund University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/830/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on MCO-HD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe