Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Modulation of Inflammation by Medium Cut Off Membranes
NCT03270371
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
NCT03437538
12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
NCT03416192
Permeability Enhancement to Reduce Chronic Inflammation
NCT01582893
Modulation of Vascular Calcification in Chronic Dialysis Patients
NCT03104166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCO-Ci 400
MCO-Ci 400 is the investigational medical product applied in hemodialysis mode
MCO-Ci 400
hemodialysis
Revaclear 400
the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode
Revaclear 400
hemodialysis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MCO-Ci 400
hemodialysis
Revaclear 400
hemodialysis
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
German Federal Ministry of Education and Research
OTHER_GOV
Gambro Dialysatoren GmbH
INDUSTRY
Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthias Girndt, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Martin-Luther-Universität Halle-Wittenberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Willy 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.
Catar 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1502
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.