Clinical trial NCT03270371: Modulation of Inflammation by Medium Cut Off Membranes
Official title: Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
End Stage Renal Disease
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in inflammation
timeFrame: 240 days (cross-over design, multiple measurements)
Secondary outcomes:
measure: Change in calcification status
timeFrame: 240 days (cross-over design, multiple measurements)
measure: change in calcification propensity
timeFrame: 240 days (cross-over design, multiple measurements)
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of nephrology, Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: attending Department of Nephrology, Klinikum rechts der Isar
name: Christoph Schmaderer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.