PERCI- Medium Cut Off (MCO)

Chronic Kidney Failure Clinical Trial

— PERCI-MCO  

Official title:

Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084381
• Other study ID #: 1502
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Inflammation
• Chronic Kidney Failure
• Inflammation
• Kidney Failure, Chronic
• Renal Insufficiency

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