Chronic Kidney DiseasesNCT03416192
12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
A study testing MCO-HD and high-flux HDF in people with Chronic Kidney Diseases and Uremia, run by Region Skane.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Uremia
- What is being tested?
- MCO-HD and high-flux HDF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing HDF treatment (>3 months)
- Oliguric
- Albumin ≥ 30
- CRP <15
- No acute myocardial infarction within 3 months.
- Swedish or english speaking.
Who cannot join
- Not able to understand the study information.
About this study
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.
- Conditions
- Chronic Kidney Diseases, Uremia
- Being tested
- MCO-HD, high-flux HDF
- Keywords
- Dialysis, MCO, Middle molecules
- Medical subject headings
- Renal Insufficiency, Chronic, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCO-HDDevice
Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.
high-flux HDFDevice
Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter
| Study group | Role | What they receive |
|---|---|---|
| MCO-HD | Experimental | Hemodialysis with Medium Cut-Off filter Receives: Device: MCO-HD; Device: high-flux HDF |
| High-flux HDF | Active comparator | Hemodiafiltration with standard high-flux filter Receives: Device: MCO-HD; Device: high-flux HDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
Measured: 12 weeks
Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
Measured: 12 weeks
Secondary outcomes (7)
Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
Measured: 12 weeks
Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
Measured: 12 weeks
Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
Measured: 12 weeks
Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
Measured: 12 weeks
Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
Measured: 8 weeks
Comparison of number of adverse effects during the study period.
Measured: 12 weeks
Comparison of mean nPCR after 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study startFeb 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Capacity shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Anders Christensson, MD, PhD, Principal investigator, Region Skane, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416192
- Sponsor's protocol ID
- 2017/830/2
- Status last verified
- Apr 2020
- First submitted
- 23 Jan 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
- ClinicalTrials.gov ID
- NCT03416192
- Acronym / sponsor ID
- 2017/830/2
- Conditions
- Chronic Kidney Diseases, Uremia
- Keywords
- Dialysis, MCO, Middle molecules
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Capacity shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Feb 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCO-HD | Experimental | Device: MCO-HD, Device: high-flux HDFHemodialysis with Medium Cut-Off filter |
| High-flux HDF | Active comparator | Device: MCO-HD, Device: high-flux HDFHemodiafiltration with standard high-flux filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ongoing HDF treatment (>3 months)
- Oliguric
- Albumin ≥ 30
- CRP <15
- No acute myocardial infarction within 3 months.
Key exclusion criteria (1 listed)
- Not able to understand the study information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCO-HDMeasurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter. | Device | High-flux HDF, MCO-HD |
| high-flux HDFMeasurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter | Device | High-flux HDF, MCO-HD |
Primary outcome
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
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
7 secondary outcomes
Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
Time frame: 12 weeks
Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
Time frame: 12 weeks
Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
Time frame: 12 weeks
Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
Time frame: 12 weeks
Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
Time frame: 8 weeks
Comparison of number of adverse effects during the study period.
Time frame: 12 weeks
Comparison of mean nPCR after 12 weeks.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Christensson, MD, PhD principal investigator
Region Skane, Lund University
Questions about this trial
What is this clinical trial studying?
A study testing MCO-HD and high-flux HDF in people with Chronic Kidney Diseases and Uremia, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.