Chronic Kidney FailureNCT03437538
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
A study testing MCO-HD and High-flux HDF in people with Chronic Kidney Failure and Uremia, run by Region Skane at 1 site in Sweden.
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 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure, Uremia, Dialysis
- 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
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 21 May 2018to 16 Apr 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
- CRP <30
- No Acute Myocardial Infarction within 3 months.
Who cannot join
- Not able to understand the study information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter
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.
- Conditions
- Chronic Kidney Failure, Uremia, Dialysis
- Being tested
- MCO-HD, High-flux HDF
- Keywords
- Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off
- Medical subject headings
- Kidney Failure, 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 during a single hemodialysis session with Medium Cut-Off filter
High-flux HDFDevice
Measurements will be done during a single hemodiafiltration session with standard high-flux filter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MCO-HD; Device: 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 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.
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%
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 240 minutes
Secondary outcomes (11)
RR of large molecules (Albumin, Transferrin, IgG)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Measured: 4 hours
RR of small molecules (Urea, Phosphate, Creatinine)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Measured: 4 hours
Number of Adverse Events
Number of adverse events during a 4h dialysis session
Measured: 4 hours
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Measured: 30 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Measured: 60 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Measured: 120 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Measured: 240 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Measured: 30 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Measured: 60 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Measured: 120 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start21 May 2018
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT03437538
- Sponsor's protocol ID
- 2017/830/1
- Status last verified
- Nov 2019
- First submitted
- 22 Jan 2018
- Last updated
- 13 Nov 2019
- 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 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter
- ClinicalTrials.gov ID
- NCT03437538
- Acronym / sponsor ID
- 2017/830/1
- Conditions
- Chronic Kidney Failure, Uremia, Dialysis
- Keywords
- Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 21 May 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 19 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First MCO-HD, then High-flux-HDF | Active comparator | Device: MCO-HD, Device: High-flux HDFParticipants 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 |
| First High-flux-HDF, then MCO-HD | Active comparator | Device: MCO-HD, Device: High-flux HDFParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ongoing HDF treatment
- CRP <30
- 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 during a single hemodialysis session with Medium Cut-Off filter | Device | First High-flux-HDF, then MCO-HD, First MCO-HD, then High-flux-HDF |
| High-flux HDFMeasurements will be done during a single hemodiafiltration session with standard high-flux filter | Device | First High-flux-HDF, then MCO-HD, First MCO-HD, then High-flux-HDF |
Primary outcome
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Time frame: 4 hours
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Time frame: 30 minutes
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Time frame: 60 minutes
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Time frame: 120 minutes
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Time frame: 240 minutes
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
11 secondary outcomes
RR of large molecules (Albumin, Transferrin, IgG)
Time frame: 4 hours
RR of small molecules (Urea, Phosphate, Creatinine)
Time frame: 4 hours
Number of Adverse Events
Time frame: 4 hours
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Time frame: 30 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Time frame: 60 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Time frame: 120 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Time frame: 240 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Time frame: 30 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Time frame: 60 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Time frame: 120 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCO-HD and High-flux HDF in people with Chronic Kidney Failure and Uremia, run by Region Skane at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) (time frame: 4 hours). The study lists 5 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 13 Nov 2019.