Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Device: A medium cut-off dialyzer (Theranova) will be used for HDx.
* Device: A synthetic high-flux dialyzer (Polyflux)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expanded hemodialysis (HDx)<br>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 | Device: A medium cut-off dialyzer (Theranova) will be used for HDx.<br>* 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)<br>|
| Active Comparator: Conventional hemodialysis<br>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 | Device: A synthetic high-flux dialyzer (Polyflux)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of sarcopenia | Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1) | Changes in serum level of Myostatin and IGF-1 every 6 months |