NCT03437538

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 major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter. Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 21, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

January 22, 2018

Last Update Submit

November 11, 2019

Conditions

Chronic Kidney FailureUremiaDialysis

Keywords

DialysisMCOMiddle moleculesHigh Retention OnsetMedium Cut-Off

Outcome Measures

Primary Outcomes (5)

  • Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%

    4 hours

  • Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

    30 minutes

  • Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

    60 minutes

  • Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

    120 minutes

  • Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

    240 minutes

Secondary Outcomes (11)

  • RR of large molecules (Albumin, Transferrin, IgG)

    4 hours

  • RR of small molecules (Urea, Phosphate, Creatinine)

    4 hours

  • Number of Adverse Events

    4 hours

  • Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    30 minutes

  • Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    60 minutes

  • +6 more secondary outcomes

Study Arms (2)

First MCO-HD, then High-flux-HDF

ACTIVE COMPARATOR

Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF

Device: MCO-HDDevice: High-flux HDF

First High-flux-HDF, then MCO-HD

ACTIVE COMPARATOR

Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD

Device: MCO-HDDevice: High-flux HDF

Interventions

MCO-HDDEVICE

Measurements will be done during a single hemodialysis session with Medium Cut-Off filter

First High-flux-HDF, then MCO-HDFirst MCO-HD, then High-flux-HDF
High-flux HDFDEVICE

Measurements will be done during a single hemodiafiltration session with standard high-flux filter

First High-flux-HDF, then MCO-HDFirst MCO-HD, then High-flux-HDF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ongoing HDF treatment
  • CRP \<30
  • No Acute Myocardial Infarction within 3 months.

You may not qualify if:

  • Not able to understand the study information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, ChronicUremia

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Christensson, MD, PhD

    Region Skane, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 19, 2018

Study Start

May 21, 2018

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)