Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Biomarkers of sarcopenia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Expanded hemodialysis (HDx)
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
Intervention: A medium cut-off dialyzer (Theranova) will be used for HDx. (Device)
Conventional hemodialysis
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: A synthetic high-flux dialyzer (Polyflux) (Device)
Outcomes
Primary Outcomes
Biomarkers of sarcopenia
Time Frame: Changes in serum level of Myostatin and IGF-1 every 6 months
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
Secondary Outcomes
No secondary outcomes reported
Investigators
Hyeongcheon Park
Professor
Gangnam Severance Hospital