12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.

Chronic Kidney Diseases Clinical Trial

Official title:

12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03416192
• Other study ID #: 2017/830/2
• Status: Withdrawn
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• 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 aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ongoing HDF treatment (>3 months)

• Oliguric

• Albumin = 30

• CRP <15

• No acute myocardial infarction within 3 months.

• Swedish or english speaking.

Exclusion Criteria:

• Not able to understand the study information.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Uremia

Intervention

Device:
• MCO-HD
Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.
• high-flux HDF
Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).		12 weeks
Primary	Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).		12 weeks
Secondary	Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.		12 weeks
Secondary	Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.		12 weeks
Secondary	Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).		12 weeks
Secondary	Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).		12 weeks
Secondary	Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.		8 weeks
Secondary	Comparison of number of adverse effects during the study period.		12 weeks
Secondary	Comparison of mean nPCR after 12 weeks.		12 weeks