Back to resultsA Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis (HD-1)
Primary Purpose
Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Theranova 400
Elisio-19H
Sponsored by
About this trial
This is an interventional treatment trial for Hemodialysis-Associated Amyloidosis focused on measuring Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or above
- End stage kidney failure receiving hemodialysis for at least 3 years
- Currently receiving hemodialysis at our center regularly
- Written informed consent
Exclusion Criteria:
- Patients with hemodiafiltration
- Catheter-related blood stream infection in the preceding 4 weeks
- Malfunctioning of HD catheter
- Planned transfer to peritoneal dialysis or transplant within 90 days
- Pregnancy
- History of active alcohol or substance abuse in the previous 6 months
- Concurrent participation in another interventional study
- Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Sites / Locations
- Selayang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCO Dialyser
High Flux Dialyser
Arm Description
12 treatments (4 weeks) with Medium Cut-Off Dialyzer
12 treatments (4 weeks) with High Flux Dialyzer
Outcomes
Primary Outcome Measures
Removal of Beta-2-microglobulin
Changes to Beta-2-microglobulin level
Changes to Quality of Life
Changes to Quality of life Using SF-36
Secondary Outcome Measures
Inflammatory state after intervention
Changes to C-Reactive Protein Level
Changes to Quality of Life
Changes to Quality of life Using EQ-5D-5L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160351
Brief Title
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis
Acronym
HD-1
Official Title
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Selayang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Detailed Description
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
Keywords
Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCO Dialyser
Arm Type
Experimental
Arm Description
12 treatments (4 weeks) with Medium Cut-Off Dialyzer
Arm Title
High Flux Dialyser
Arm Type
Active Comparator
Arm Description
12 treatments (4 weeks) with High Flux Dialyzer
Intervention Type
Device
Intervention Name(s)
Theranova 400
Intervention Description
medium cut-off dialyser
Intervention Type
Device
Intervention Name(s)
Elisio-19H
Intervention Description
high flux dialyser
Primary Outcome Measure Information:
Title
Removal of Beta-2-microglobulin
Description
Changes to Beta-2-microglobulin level
Time Frame
4 weeks
Title
Changes to Quality of Life
Description
Changes to Quality of life Using SF-36
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
Inflammatory state after intervention
Description
Changes to C-Reactive Protein Level
Time Frame
4 weeks
Title
Changes to Quality of Life
Description
Changes to Quality of life Using EQ-5D-5L
Time Frame
27 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or above
End stage kidney failure receiving hemodialysis for at least 3 years
Currently receiving hemodialysis at our center regularly
Written informed consent
Exclusion Criteria:
Patients with hemodiafiltration
Catheter-related blood stream infection in the preceding 4 weeks
Malfunctioning of HD catheter
Planned transfer to peritoneal dialysis or transplant within 90 days
Pregnancy
History of active alcohol or substance abuse in the previous 6 months
Concurrent participation in another interventional study
Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hin Seng Wong, MD
Organizational Affiliation
Ministry of Health, Malaysia
Official's Role
Study Director
Facility Information:
Facility Name
Selayang Hospital
City
Batu Caves
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
68100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis
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