Cardiovascular DiseasesMCO-IFNCT03270371
Modulation of Inflammation by Medium Cut Off Membranes
A study testing Medium cut off dialysis and Standard High Flux Dialyzer in people with Cardiovascular Diseases and End Stage Renal Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, End Stage Renal Disease
- What is being tested?
- Medium cut off dialysis and Standard High Flux Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to Feb 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
- time since initiation of dialysis > 3 months
- age > 18 years
Who cannot join
- time since initiation of dialysis < 3 months
- age < 18 years
- ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
- major surgery less than 2 weeks before inclusion in the study
- pregnancy
- mental illness
- lack of written and informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of nephrology, Klinikum rechts der Isar
München, Bavaria, 81675
Christoph Schmaderer, M.D., 0049-89-4140 ext. 6701, christoph.schmaderer@lrz.tum.de
Georg Lorenz, M.D., 0049-89-4140 ext. 6704, georg.lorenz@googlemail.com
About this study
Official title: Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.
Read the detailed description
Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.
Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.
- Conditions
- Cardiovascular Diseases, End Stage Renal Disease
- Being tested
- Medium cut off dialysis, Standard High Flux Dialyzer
- Medical subject headings
- Cardiovascular Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium cut off dialysisDevice
Also called Theranova Dialyzer
Hemodialysis
Standard High Flux DialyzerDevice
Hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| MCO Dialysis | Experimental | Theranova Dialyzer Receives: Device: Medium cut off dialysis |
| Standard High Flux Dialysis | Active comparator | Standard High Flux Dialyzer Receives: Device: Standard High Flux Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammation
change of inflammatory score (inflammatory score is derived from multiple biomarkers)
Measured: 240 days (cross-over design, multiple measurements)
Secondary outcomes (2)
Change in calcification status
calcification score derived from several pro- and anticalcifying biomarkers
Measured: 240 days (cross-over design, multiple measurements)
change in calcification propensity
this values measures the resistence of serum to a calcification stimulus
Measured: 240 days (cross-over design, multiple measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Schmaderer, MD, Principal investigator, attending Department of Nephrology, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270371
- Sponsor's protocol ID
- MCO-CS-559/16S
- Acronym
- MCO-IF
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.
PubMed 28535525Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PubMed 28085888
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT03270371
- Acronym / sponsor ID
- MCO-IF / MCO-CS-559/16S
- Conditions
- Cardiovascular Diseases, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Sep 2017 (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.
This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.
Detailed description
Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.
Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
| Arm | Type | Receives |
|---|---|---|
| MCO Dialysis | Experimental | Device: Medium cut off dialysisTheranova Dialyzer |
| Standard High Flux Dialysis | Active comparator | Device: Standard High Flux DialyzerStandard High Flux Dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- time since initiation of dialysis > 3 months
- age > 18 years
Key exclusion criteria (7 listed)
- time since initiation of dialysis < 3 months
- age < 18 years
- ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
- major surgery less than 2 weeks before inclusion in the study
- pregnancy
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 |
|---|---|---|
| Medium cut off dialysisAlso: Theranova DialyzerHemodialysis | Device | MCO Dialysis |
| Standard High Flux DialyzerHemodialysis | Device | Standard High Flux Dialysis |
Primary outcome
Change in inflammation
Time frame: 240 days (cross-over design, multiple measurements)
change of inflammatory score (inflammatory score is derived from multiple biomarkers)
2 secondary outcomes
Change in calcification status
Time frame: 240 days (cross-over design, multiple measurements)
change in calcification propensity
Time frame: 240 days (cross-over design, multiple measurements)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 28535525Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.
- Background: PubMed 28085888Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
- 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.
Christoph Schmaderer, MD principal investigator
attending Department of Nephrology, Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium cut off dialysis and Standard High Flux Dialyzer in people with Cardiovascular Diseases and End Stage Renal Disease, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Schmaderer, MD (0049894140 ext. 5053, christoph.schmaderer@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammation (time frame: 240 days (cross-over design, multiple measurements)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270371, which also lists 2 linked publications.
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 1 Sep 2017.