Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

Gangnam Severance Hospital47 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

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

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)

A synthetic high-flux dialyzer (Polyflux)DEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Biomarkers of sarcopenia

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

Data from ClinicalTrials.gov

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