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NCT04585607 Clinical Trial

Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04585607
Other study ID # 3-2020-0337
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 19, 2020
Est. completion date July 7, 2022

Study information
Verified date August 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date July 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• A 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)
• A 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.

Locations
Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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