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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sarcopenia

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