CClinicalTrials.gg
WithdrawnNCT03416192Updated Apr 15, 2020

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

An interventional study of MCO-HD and high-flux HDF in Chronic Kidney Diseases and Uremia, sponsored by Region Skane. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Capacity shortage
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Diseases
  • Uremia

Keywords

  • Dialysis
  • MCO
  • Middle molecules
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Not able to understand the study information.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MCO-HD

    Hemodialysis with Medium Cut-Off filter

    Device: MCO-HD · Device: high-flux HDF

  • Active comparator
    High-flux HDF

    Hemodiafiltration with standard high-flux filter

    Device: MCO-HD · Device: high-flux HDF

Interventions

  • DeviceMCO-HD

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

  • Devicehigh-flux HDF

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

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.

    Time frame: 12 weeks

  2. Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.

    Time frame: 12 weeks

  3. Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).

    Time frame: 12 weeks

  4. Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).

    Time frame: 12 weeks

  5. Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.

    Time frame: 8 weeks

  6. Comparison of number of adverse effects during the study period.

    Time frame: 12 weeks

  7. Comparison of mean nPCR after 12 weeks.

    Time frame: 12 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03416192
Lead sponsor
Region Skane
Collaborators
Lund University
Responsible party
Sponsor
First posted
Jan 31, 2018
Start date
Feb 2019 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Apr 15, 2020

Study contacts

Anders Christensson, MD, PhD
principal investigator · Region Skane, Lund University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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