Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

NCT04585607 | Completed Phase 4 DMC

• 1 other identifier: 3-2020-0337
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Expanded hemodialysis (HDx)

EXPERIMENTAL

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.

Conventional hemodialysis

ACTIVE COMPARATOR

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)

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)

Expanded hemodialysis (HDx)

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.

Conventional hemodialysis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On HD treatment over 6 months before study enrollment
• Aged over 18 years
• Able to give informed consent

You may not qualify if:

• Hemiplegia or paraplegia state
• Planned renal transplant or conversion to peritoneal dialysis within study period
• Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
• History of monoclonal gammopathy
• Life expectancy \<12 months
• Pregnancy or breast feeding
• Receiving immunosuppressant medication
• Inability to complete study assessments

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 14, 2020
• Study Start: October 19, 2020
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)