Modulation of Inflammation by Medium Cut Off Membranes (MCO-IF)

Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease

This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; End Stage Renal Disease
• Intervention / Treatment: Device: Medium cut off dialysis; Device: Standard High Flux Dialyzer

Detailed Description

Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.

Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Recruiting
      • Department of nephrology, Klinikum rechts der Isar
      • Contact: Christoph Schmaderer, M.D.; Phone Number: 6701 0049-89-4140; Email: christoph.schmaderer@lrz.tum.de
      • Contact: Georg Lorenz, M.D.; Phone Number: 6704 0049-89-4140; Email: georg.lorenz@googlemail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• time since initiation of dialysis > 3 months
• age > 18 years

Exclusion Criteria:

• time since initiation of dialysis < 3 months
• age < 18 years
• ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
• major surgery less than 2 weeks before inclusion in the study
• pregnancy
• mental illness
• lack of written and informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCO Dialysis; Theranova Dialyzer	Device: Medium cut off dialysis; Hemodialysis; Other Names: Theranova Dialyzer
Active Comparator: Standard High Flux Dialysis; Standard High Flux Dialyzer	Device: Standard High Flux Dialyzer; Hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammation	change of inflammatory score (inflammatory score is derived from multiple biomarkers)	240 days (cross-over design, multiple measurements)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in calcification status	calcification score derived from several pro- and anticalcifying biomarkers	240 days (cross-over design, multiple measurements)
change in calcification propensity	this values measures the resistence of serum to a calcification stimulus	240 days (cross-over design, multiple measurements)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Christoph Schmaderer, MD, attending Department of Nephrology, Klinikum rechts der Isar

Publications and helpful links

General Publications

• Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: MCO-CS-559/16S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No