PERCI- Medium Cut Off (MCO)

Not Applicable

Completed

• Conditions: Chronic Kidney Failure; Chronic Inflammation
• Interventions: Device: Revaclear 400; Device: MCO-Ci 400

• Registration Number: NCT02084381
• Lead Sponsor: Vantive Health LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-12
• Primary Completion: 2014-07
• Study Completion: 2015-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Revaclear 400	Revaclear 400	the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode
MCO-Ci 400	MCO-Ci 400	MCO-Ci 400 is the investigational medical product applied in hemodialysis mode

Primary Outcome Measures

Name	Time	Method
TNF-alpha mRNA	4 weeks treatment time	Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells

Secondary Outcome Measures

Name	Time	Method
safety related events	6 month

Trial Locations

Locations (2)

Martin-Luther-Universität Halle-Wittenberg; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany