PERCI- Medium Cut Off (MCO)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084381

Acronym

PERCI-MCO

Enrollment

Registered

2014-03-12

Start date

2014-02-28

Completion date

2015-02-28

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammation, Chronic Kidney Failure

Keywords

CKD5, dialysis, high porous membranes

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.

Interventions

DEVICEMCO-Ci 400

hemodialysis

DEVICERevaclear 400

hemodialysis

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
safety related events	6 month

Other

Measure	Time frame	Description
Exploratory	12 weeks	Elimination of inflammatory molecules and uremic toxins from patient's blood

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026