Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

• Sponsor: Region Skane (Other)
• Overall Status: Completed
• CT.gov ID: NCT03437538
• Collaborator: Lund University (Other)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Failure; Uremia; Dialysis	Device: MCO-HD; Device: High-flux HDF	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 21, 2018
• Actual Primary Completion Date: Apr 16, 2019
• Actual Study Completion Date: Apr 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: First MCO-HD, then High-flux-HDF Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF	Device: MCO-HD; Measurements will be done during a single hemodialysis session with Medium Cut-Off filter; Device: High-flux HDF; Measurements will be done during a single hemodiafiltration session with standard high-flux filter
Active Comparator: First High-flux-HDF, then MCO-HD Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD	Device: MCO-HD; Measurements will be done during a single hemodialysis session with Medium Cut-Off filter; Device: High-flux HDF; Measurements will be done during a single hemodiafiltration session with standard high-flux filter

Outcome Measures

Primary Outcome Measures

1. Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) [4 hours]

   Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

2. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) [30 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

3. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) [60 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

4. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) [120 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

5. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin) [240 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Secondary Outcome Measures

1. RR of large molecules (Albumin, Transferrin, IgG) [4 hours]

   Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

2. RR of small molecules (Urea, Phosphate, Creatinine) [4 hours]

   Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

3. Number of Adverse Events [4 hours]

   Number of adverse events during a 4h dialysis session

4. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) [30 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

5. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) [60 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

6. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) [120 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

7. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) [240 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

8. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) [30 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

9. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) [60 minutes]

   Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

10. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) [120 minutes]

    Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

11. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) [240 minutes]

    Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ongoing HDF treatment

• CRP <30

• No Acute Myocardial Infarction within 3 months.

Exclusion Criteria:

• Not able to understand the study information.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skane University Hospital	Malmö		Sweden

Sponsors and Collaborators

• Region Skane
• Lund University

Investigators

• Principal Investigator: Anders Christensson, MD, PhD, Region Skane, Lund University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT03437538
• Other Study ID Numbers: 2017/830/1
• First Posted: Feb 19, 2018
• Last Update Posted: Nov 13, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Region Skane: Dialysis; MCO; Middle molecules; High Retention Onset; Medium Cut-Off
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic

Study Results

No Results Posted as of Nov 13, 2019