Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

Phase 4

Completed

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Device: A medium cut-off dialyzer (Theranova) will be used for HDx.; Device: A synthetic high-flux dialyzer (Polyflux)

• Registration Number: NCT04585607
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2020-10-19
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expanded hemodialysis (HDx)	A medium cut-off dialyzer (Theranova) will be used for HDx.	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
Conventional hemodialysis	A synthetic high-flux dialyzer (Polyflux)	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of