Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Device: A synthetic high-flux dialyzer (Polyflux); Device: A medium cut-off dialyzer (Theranova) will be used for HDx.

Study type: Interventional

Funder types: Other

Identifiers

NCT04585607

3-2020-0337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Expanded hemodialysis (HDx)

Experimental group

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

Treatment:

Device: A medium cut-off dialyzer (Theranova) will be used for HDx.

Conventional hemodialysis

Active Comparator group

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

Treatment:

Device: A synthetic high-flux dialyzer (Polyflux)