Chronic Kidney Failure Clinical Trial
— PERCI-MCOOfficial title:
Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
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 |
Verified date | February 2022 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Martin-Luther-Universität Halle-Wittenberg | Halle | Sachsen-Anhalt |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation | Gambro Dialysatoren GmbH, German Federal Ministry of Education and Research |
Germany,
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
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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