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

Primary Purpose

Chronic Kidney Failure, Chronic Inflammation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MCO-Ci 400
Revaclear 400
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring CKD5, dialysis, high porous membranes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Martin-Luther-Universität Halle-Wittenberg
  • Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCO-Ci 400

Revaclear 400

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

safety related events

Full Information

First Posted
February 7, 2014
Last Updated
February 17, 2022
Sponsor
Baxter Healthcare Corporation
Collaborators
German Federal Ministry of Education and Research, Gambro Dialysatoren GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02084381
Brief Title
PERCI- Medium Cut Off (MCO)
Acronym
PERCI-MCO
Official Title
Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
German Federal Ministry of Education and Research, Gambro Dialysatoren GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure, Chronic Inflammation
Keywords
CKD5, dialysis, high porous membranes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCO-Ci 400
Arm Type
Experimental
Arm Description
MCO-Ci 400 is the investigational medical product applied in hemodialysis mode
Arm Title
Revaclear 400
Arm Type
Active Comparator
Arm Description
the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode
Intervention Type
Device
Intervention Name(s)
MCO-Ci 400
Intervention Description
hemodialysis
Intervention Type
Device
Intervention Name(s)
Revaclear 400
Other Intervention Name(s)
standard high flux dialyzer
Intervention Description
hemodialysis
Primary Outcome Measure Information:
Title
TNF-alpha mRNA
Description
Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells
Time Frame
4 weeks treatment time
Secondary Outcome Measure Information:
Title
safety related events
Time Frame
6 month
Other Pre-specified Outcome Measures:
Title
Exploratory
Description
Elimination of inflammatory molecules and uremic toxins from patient's blood
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Girndt, Prof. Dr.
Organizational Affiliation
Martin-Luther-Universität Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28085888
Citation
Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
Results Reference
result
PubMed Identifier
29402827
Citation
Willy K, Girndt M, Voelkl J, Fiedler R, Martus P, Storr M, Schindler R, Zickler D. Expanded Haemodialysis Therapy of Chronic Haemodialysis Patients Prevents Calcification and Apoptosis of Vascular Smooth Muscle Cells in vitro. Blood Purif. 2018;45(1-3):131-138. doi: 10.1159/000484925. Epub 2017 Dec 22.
Results Reference
result
PubMed Identifier
34858433
Citation
Catar R, Moll G, Kamhieh-Milz J, Luecht C, Chen L, Zhao H, Ernst L, Willy K, Girndt M, Fiedler R, Witowski J, Morawietz H, Ringden O, Dragun D, Eckardt KU, Schindler R, Zickler D. Expanded Hemodialysis Therapy Ameliorates Uremia-Induced Systemic Microinflammation and Endothelial Dysfunction by Modulating VEGF, TNF-alpha and AP-1 Signaling. Front Immunol. 2021 Nov 11;12:774052. doi: 10.3389/fimmu.2021.774052. eCollection 2021.
Results Reference
result

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PERCI- Medium Cut Off (MCO)

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