Clinical trial NCT02084381: PERCI- Medium Cut Off (MCO)
Official title: Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Failure
Chronic Inflammation
Keywords: CKD5, dialysis, high porous membranes
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: German Federal Ministry of Education and Research
name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2014-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: TNF-alpha mRNA
timeFrame: 4 weeks treatment time
Secondary outcomes:
measure: safety related events
timeFrame: 6 month
Other outcomes:
measure: Exploratory
timeFrame: 12 weeks
Locations:
city: Halle
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Matthias Girndt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.