NCT02084381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 7, 2014

Last Update Submit

March 11, 2025

Conditions

Chronic Kidney FailureChronic Inflammation

Keywords

CKD5, dialysis, high porous membranes

Outcome Measures

Primary Outcomes (1)

  • TNF-alpha mRNA

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

    4 weeks treatment time

Secondary Outcomes (1)

  • safety related events

    6 month

Other Outcomes (1)

  • Exploratory

    12 weeks

Study Arms (2)

MCO-Ci 400

EXPERIMENTAL

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

Device: MCO-Ci 400

Revaclear 400

ACTIVE COMPARATOR

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

Device: Revaclear 400

Interventions

MCO-Ci 400DEVICE

hemodialysis

MCO-Ci 400
Revaclear 400DEVICE

hemodialysis

Also known as: standard high flux dialyzer
Revaclear 400

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, 06120, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (3)

  • 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.

    PMID: 28085888RESULT

  • 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.

    PMID: 29402827RESULT

  • 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.

    PMID: 34858433RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Girndt, Prof. Dr.

    Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

March 12, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

February 1, 2015

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DE(2)