PERCI- Medium Cut Off (MCO) (PERCI-MCO)

Vantive Health LLC

Status: Completed

Conditions: Chronic Kidney Failure; Chronic Inflammation

Treatments: Device: Revaclear 400; Device: MCO-Ci 400

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02084381

1502

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MCO-Ci 400

Experimental group

Description:

MCO-Ci 400 is the investigational medical product applied in hemodialysis mode

Treatment:

Device: MCO-Ci 400

Revaclear 400

Active Comparator group

Description:

the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode

Treatment:

Device: Revaclear 400