Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04585607
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Chronic Dialysis	Device: A medium cut-off dialyzer (Theranova) will be used for HDx.; Device: A synthetic high-flux dialyzer (Polyflux)	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 19, 2020
• Anticipated Primary Completion Date: Sep 23, 2023
• Anticipated Study Completion Date: Sep 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expanded hemodialysis (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	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)
Active Comparator: Conventional hemodialysis 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	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyeongcheon Park, Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT04585607
• Other Study ID Numbers: 3-2020-0337
• First Posted: Oct 14, 2020
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia; Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Aug 3, 2022