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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO-Ci 400 | Experimental | MCO-Ci 400 is the investigational medical product applied in hemodialysis mode |
|
| Revaclear 400 | Active Comparator | the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCO-Ci 400 | Device | hemodialysis |
| |
| Revaclear 400 |
| Measure | Description | Time Frame |
|---|---|---|
| TNF-alpha mRNA | Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells | 4 weeks treatment time |
| Measure | Description | Time Frame |
|---|---|---|
| safety related events | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory | Elimination of inflammatory molecules and uremic toxins from patient's blood | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Girndt, Prof. Dr. | Martin-Luther-Universität Halle-Wittenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martin-Luther-Universität Halle-Wittenberg | Halle | Saxony-Anhalt | 06120 | Germany | ||
| Charité - Universitätsmedizin Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28085888 | Result | 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. | |
| 29402827 |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Device |
hemodialysis |
|
|
| Berlin |
| 13353 |
| Germany |
| Result |
| 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. |
| 34858433 | Result | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |