Clinical trial NCT03437538: Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
Official title: Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Failure
Uremia
Dialysis
Keywords: Dialysis
MCO
Middle molecules
High Retention Onset
Medium Cut-Off
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2018-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.

Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.


Eligibility criteria: Inclusion Criteria:

* Ongoing HDF treatment
* CRP \<30
* No Acute Myocardial Infarction within 3 months.

Exclusion Criteria:

* Not able to understand the study information.

Primary outcomes:
measure: Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
timeFrame: 4 hours
measure: Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
timeFrame: 30 minutes
measure: Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
timeFrame: 60 minutes
measure: Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
timeFrame: 120 minutes
measure: Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
timeFrame: 240 minutes
Secondary outcomes:
measure: RR of large molecules (Albumin, Transferrin, IgG)
timeFrame: 4 hours
measure: RR of small molecules (Urea, Phosphate, Creatinine)
timeFrame: 4 hours
measure: Number of Adverse Events
timeFrame: 4 hours
measure: Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
timeFrame: 30 minutes
measure: Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
timeFrame: 60 minutes
measure: Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
timeFrame: 120 minutes
measure: Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
timeFrame: 240 minutes
measure: Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
timeFrame: 30 minutes
measure: Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
timeFrame: 60 minutes
measure: Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
timeFrame: 120 minutes
measure: Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Region Skane, Lund University
name: Anders Christensson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: