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

February 17, 2022 updated by: Baxter Healthcare Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Martin-Luther-Universität Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCO-Ci 400
MCO-Ci 400 is the investigational medical product applied in hemodialysis mode
Device: MCO-Ci 400
hemodialysis
Active Comparator: Revaclear 400
the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode
Device: Revaclear 400
hemodialysis
Other Names:
  • standard high flux dialyzer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
safety related events
Time Frame: 6 month
6 month

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

German Federal Ministry of Education and Research
Gambro Dialysatoren GmbH

Investigators

  • Principal Investigator: Matthias Girndt, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Inflammation

Clinical Trials on MCO-Ci 400

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe