Back to resultsPotential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
Primary Purpose
Chronic Kidney Disease Requiring Chronic Dialysis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
A medium cut-off dialyzer (Theranova) will be used for HDx.
A synthetic high-flux dialyzer (Polyflux)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis
Eligibility Criteria
Inclusion Criteria:
- On HD treatment over 6 months before study enrollment
- Aged over 18 years
- Able to give informed consent
Exclusion Criteria:
- Hemiplegia or paraplegia state
- Planned renal transplant or conversion to peritoneal dialysis within study period
- Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
- History of monoclonal gammopathy
- Life expectancy <12 months
- Pregnancy or breast feeding
- Receiving immunosuppressant medication
- Inability to complete study assessments
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Expanded hemodialysis (HDx)
Conventional hemodialysis
Arm Description
HDx therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
Conventional hemodialysis therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
Outcomes
Primary Outcome Measures
Biomarkers of sarcopenia
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
Secondary Outcome Measures
Full Information
NCT ID
NCT04585607
First Posted
September 28, 2020
Last Updated
August 7, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04585607
Brief Title
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
Official Title
Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.
Detailed Description
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expanded hemodialysis (HDx)
Arm Type
Experimental
Arm Description
HDx therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
Arm Title
Conventional hemodialysis
Arm Type
Active Comparator
Arm Description
Conventional hemodialysis therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
Intervention Type
Device
Intervention Name(s)
A medium cut-off dialyzer (Theranova) will be used for HDx.
Intervention Description
A medium cut-off dialyzer used for HDx (Theranova) must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription.
HD with MCO dialyzer (Theranova 400®, Baxter) vs. high-flux dialyzer (eg. Polyflux H, Baxter)
Intervention Type
Device
Intervention Name(s)
A synthetic high-flux dialyzer (Polyflux)
Intervention Description
A synthetic high-flux dialyzer (Polyflux) used for hemodialysis must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required.
Primary Outcome Measure Information:
Title
Biomarkers of sarcopenia
Description
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
Time Frame
Changes in serum level of Myostatin and IGF-1 every 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On HD treatment over 6 months before study enrollment
Aged over 18 years
Able to give informed consent
Exclusion Criteria:
Hemiplegia or paraplegia state
Planned renal transplant or conversion to peritoneal dialysis within study period
Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
History of monoclonal gammopathy
Life expectancy <12 months
Pregnancy or breast feeding
Receiving immunosuppressant medication
Inability to complete study assessments
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
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