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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084381
Other study ID # 1502
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date February 2015

Study information

Verified date February 2022
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2015
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

Device:
MCO-Ci 400
hemodialysis
Revaclear 400
hemodialysis

Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Martin-Luther-Universität Halle-Wittenberg Halle Sachsen-Anhalt

Sponsors (3)

Lead Sponsor Collaborator
Baxter Healthcare Corporation Gambro Dialysatoren GmbH, German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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, Ringdén O, Dragun D, Eckardt KU, Schindler R, Zickler D. Expanded Hemodialysis Therapy Ameliorates Uremia-Induced Systemic Microinfl — View 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):13 — View 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 Patie — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory Elimination of inflammatory molecules and uremic toxins from patient's blood 12 weeks
Primary TNF-alpha mRNA Significant lower pre- dialytic TNF-a mRNA expression level in circulating peripheral blood mononuclear cells 4 weeks treatment time
Secondary safety related events 6 month
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