Chronic Kidney FailurePERCI-MCONCT02084381
PERCI- Medium Cut Off (MCO)
A study testing MCO-Ci 400 and Revaclear 400 in people with Chronic Kidney Failure and Chronic Inflammation, run by Vantive Health LLC at 2 sites in Germany.
Trial summary
The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Failure, Chronic Inflammation
- What is being tested?
- MCO-Ci 400 and Revaclear 400
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2014to Feb 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD5 ( GFR < 15ml/min/ 1.73m2)
- Dialysis treatment for ≥ 3 months
- Dialysis 3x weekly
- Vascular access by fistula or CVC
- Age > 18 and < 99 Years
- Ability to give written informed consent
Who cannot join
- Missing informed consent form
- current clinically manifested infection or within the last two weeks
- current CRP-value > 50mg/L or within the last two weeks
- Intake of any medication applied for immunosuppressive purposes
- Pregnancy or lactation
- Participation in a different interventional study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
About this study
Official title: Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa).
The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.
- Conditions
- Chronic Kidney Failure, Chronic Inflammation
- Being tested
- MCO-Ci 400, Revaclear 400
- Keywords
- CKD5, dialysis, high porous membranes
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCO-Ci 400Device
hemodialysis
Revaclear 400Device
Also called standard high flux dialyzer
hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| MCO-Ci 400 | Experimental | MCO-Ci 400 is the investigational medical product applied in hemodialysis mode Receives: Device: MCO-Ci 400 |
| Revaclear 400 | Active comparator | the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode Receives: Device: Revaclear 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha mRNA
Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells
Measured: 4 weeks treatment time
Secondary outcomes (1)
safety related events
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research, Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Matthias Girndt, Prof. Dr., Principal investigator, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084381
- Sponsor's protocol ID
- 1502
- Acronym
- PERCI-MCO
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2014
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Zickler 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 28085888Willy K, Girndt M, Voelkl J, Fiedler R, Martus P, Storr M, Schindler R, Zickler D. Expanded Haemodialysis Therapy of Chronic Haemodialysis Patients Prevents Calcification and Apoptosis of Vascular Smooth Muscle Cells in vitro. Blood Purif. 2018;45(1-3):131-138. doi: 10.1159/000484925. Epub 2017 Dec 22.
PubMed 29402827Catar R, Moll G, Kamhieh-Milz J, Luecht C, Chen L, Zhao H, Ernst L, Willy K, Girndt M, Fiedler R, Witowski J, Morawietz H, Ringden O, Dragun D, Eckardt KU, Schindler R, Zickler D. Expanded Hemodialysis Therapy Ameliorates Uremia-Induced Systemic Microinflammation and Endothelial Dysfunction by Modulating VEGF, TNF-alpha and AP-1 Signaling. Front Immunol. 2021 Nov 11;12:774052. doi: 10.3389/fimmu.2021.774052. eCollection 2021.
PubMed 34858433
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
- ClinicalTrials.gov ID
- NCT02084381
- Acronym / sponsor ID
- PERCI-MCO / 1502
- Conditions
- Chronic Kidney Failure, Chronic Inflammation
- Keywords
- CKD5, dialysis, high porous membranes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research, Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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 membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa).
The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCO-Ci 400 | Experimental | Device: MCO-Ci 400MCO-Ci 400 is the investigational medical product applied in hemodialysis mode |
| Revaclear 400 | Active comparator | Device: Revaclear 400the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CKD5 ( GFR < 15ml/min/ 1.73m2)
- Dialysis treatment for ≥ 3 months
- Dialysis 3x weekly
- Vascular access by fistula or CVC
- Age > 18 and < 99 Years
Key exclusion criteria (6 listed)
- Missing informed consent form
- current clinically manifested infection or within the last two weeks
- current CRP-value > 50mg/L or within the last two weeks
- Intake of any medication applied for immunosuppressive purposes
- Pregnancy or lactation
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-Ci 400hemodialysis | Device | MCO-Ci 400 |
| Revaclear 400Also: standard high flux dialyzerhemodialysis | Device | Revaclear 400 |
Primary outcome
TNF-alpha mRNA
Time frame: 4 weeks treatment time
Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells
1 secondary outcome
safety related events
Time frame: 6 month
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 Mar 2025.
- Results publication: 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.
- Results publication: PubMed 29402827Willy K, Girndt M, Voelkl J, Fiedler R, Martus P, Storr M, Schindler R, Zickler D. Expanded Haemodialysis Therapy of Chronic Haemodialysis Patients Prevents Calcification and Apoptosis of Vascular Smooth Muscle Cells in vitro. Blood Purif. 2018;45(1-3):131-138. doi: 10.1159/000484925. Epub 2017 Dec 22.
- Results publication: PubMed 34858433Catar R, Moll G, Kamhieh-Milz J, Luecht C, Chen L, Zhao H, Ernst L, Willy K, Girndt M, Fiedler R, Witowski J, Morawietz H, Ringden O, Dragun D, Eckardt KU, Schindler R, Zickler D. Expanded Hemodialysis Therapy Ameliorates Uremia-Induced Systemic Microinflammation and Endothelial Dysfunction by Modulating VEGF, TNF-alpha and AP-1 Signaling. Front Immunol. 2021 Nov 11;12:774052. doi: 10.3389/fimmu.2021.774052. eCollection 2021.
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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.
Matthias Girndt, Prof. Dr. principal investigator
Martin-Luther-Universität Halle-Wittenberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCO-Ci 400 and Revaclear 400 in people with Chronic Kidney Failure and Chronic Inflammation, run by Vantive Health LLC at 2 sites 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 6 inclusion and 6 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
TNF-alpha mRNA (time frame: 4 weeks treatment time). 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 NCT02084381, which also lists 3 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 13 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.