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Completed

NCT Number: NCT04585607

Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

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.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

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.

Primary outcomes

  1. Biomarkers of sarcopenia

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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