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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03437538
Other study ID # 2017/830/1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2018
Est. completion date April 16, 2019

Study information

Verified date November 2019
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 16, 2019
Est. primary completion date April 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ongoing HDF treatment

- CRP <30

- No Acute Myocardial Infarction within 3 months.

Exclusion Criteria:

- Not able to understand the study information.

Study Design


Intervention

Device:
MCO-HD
Measurements will be done during a single hemodialysis session with Medium Cut-Off filter
High-flux HDF
Measurements will be done during a single hemodiafiltration session with standard high-flux filter

Locations

Country Name City State
Sweden Skane University Hospital Malmö

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100% 4 hours
Primary Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis. 30 minutes
Primary Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis. 60 minutes
Primary Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis. 120 minutes
Primary Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis. 240 minutes
Secondary RR of large molecules (Albumin, Transferrin, IgG) Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100% 4 hours
Secondary RR of small molecules (Urea, Phosphate, Creatinine) Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100% 4 hours
Secondary Number of Adverse Events Number of adverse events during a 4h dialysis session 4 hours
Secondary Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis. 30 minutes
Secondary Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis. 60 minutes
Secondary Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis. 120 minutes
Secondary Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis. 240 minutes
Secondary Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis. 30 minutes
Secondary Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis. 60 minutes
Secondary Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis. 120 minutes
Secondary Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis. 240 minutes
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