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Completed

NCT Number: NCT02084381

PERCI- Medium Cut Off (MCO)

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.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Chronic Inflammation Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martin-Luther-Universität Halle-Wittenberg, Halle, Saxony-Anhalt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCO-Ci 400

Device

hemodialysis

Revaclear 400

Device

hemodialysis

Other names: standard high flux dialyzer

Primary outcomes

  1. TNF-alpha mRNA

    Time frame: 4 weeks treatment time

    Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells

Secondary outcomes

  1. safety related events

    Time frame: 6 month

Other outcomes

  1. Exploratory

    Time frame: 12 weeks

    Elimination of inflammatory molecules and uremic toxins from patient's blood

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH
  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: PERCI-MCO

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 12, 2014
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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