Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
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.
Interventions
DEVICEA medium cut-off dialyzer (Theranova) will be used for HDx.
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)
DEVICEA synthetic high-flux dialyzer (Polyflux)
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
1. Hemiplegia or paraplegia state 2. Planned renal transplant or conversion to peritoneal dialysis within study period 3. Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy 4. History of monoclonal gammopathy 5. Life expectancy \<12 months 6. Pregnancy or breast feeding 7. Receiving immunosuppressant medication 8. Inability to complete study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of sarcopenia | 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) |
Countries
South Korea
Outcome results
None listed