Modulation of Inflammation by Medium Cut Off Membranes

Cardiovascular Diseases Clinical Trial

— MCO-IF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270371
• Other study ID #: MCO-CS-559/16S
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2017
• Last updated: August 29, 2017
• Start date: September 1, 2017
• Est. completion date: February 2019

Study information

• Verified date: August 2017
• Source: Technische Universität München
• Contact: Christoph Schmaderer, MD
• Phone: 0049894140
• Email: christoph.schmaderer[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Medium cut off dialysis
Hemodialysis
• Standard High Flux Dialyzer
Hemodialysis

Locations

Country	Name	City	State
Germany	Department of nephrology, Klinikum rechts der Isar	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammation	change of inflammatory score (inflammatory score is derived from multiple biomarkers)	240 days (cross-over design, multiple measurements)
Secondary	Change in calcification status	calcification score derived from several pro- and anticalcifying biomarkers	240 days (cross-over design, multiple measurements)
Secondary	change in calcification propensity	this values measures the resistence of serum to a calcification stimulus	240 days (cross-over design, multiple measurements)