Modulation of Inflammation by Medium Cut Off Membranes

NCT03270371 | Unknown

• 1 other identifier: MCO-CS-559/16S
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Change in inflammation

  change of inflammatory score (inflammatory score is derived from multiple biomarkers)

  240 days (cross-over design, multiple measurements)

Secondary Outcomes (2)

• Change in calcification status

  240 days (cross-over design, multiple measurements)

• change in calcification propensity

  240 days (cross-over design, multiple measurements)

Study Arms (2)

MCO Dialysis

EXPERIMENTAL

Theranova Dialyzer

Device: Medium cut off dialysis

Standard High Flux Dialysis

ACTIVE COMPARATOR

Standard High Flux Dialyzer

Device: Standard High Flux Dialyzer

Interventions

Medium cut off dialysis DEVICE

Hemodialysis

Also known as: Theranova Dialyzer

MCO Dialysis

Standard High Flux Dialyzer DEVICE

Hemodialysis

Standard High Flux Dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• time since initiation of dialysis \< 3 months
• age \< 18 years
• ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
• pregnancy
• mental illness
• lack of written and informed consent

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of nephrology, Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Related 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.

  PMID: 28535525 BACKGROUND

• 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: 28085888 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Schmaderer, MD

  attending Department of Nephrology, Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schmaderer, MD

CONTACT

0049894140; christoph.schmaderer@mri.tum.de

Georg Lorenz, MD

CONTACT

0049894140; georg.lorenz@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 1, 2017
• Study Start: September 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)