Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

NCT ID: NCT04585607

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2022-07-07

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

A medium cut-off dialyzer (Theranova) will be used for HDx.

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

A synthetic high-flux dialyzer (Polyflux)

Intervention Type 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.

Interventions

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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)

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyeongcheon Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2020-0337

Identifier Type: -

Identifier Source: org_study_id

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