Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

NCT ID: NCT04211571

Last Updated: 2023-11-21

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2023-09-24

Brief Summary

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Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCO group

Hemodialysis using Theranova 400 dialyzer

Group Type EXPERIMENTAL

Theranova 400 dialyzer

Intervention Type DEVICE

Hemodialysis using Theranova 400 dialyzer

High-flux group

Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)

Group Type ACTIVE_COMPARATOR

High-flux dialyzer

Intervention Type DEVICE

Hemodialysis using high-flux dialyzer

Interventions

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Theranova 400 dialyzer

Hemodialysis using Theranova 400 dialyzer

Intervention Type DEVICE

High-flux dialyzer

Hemodialysis using high-flux dialyzer

Intervention Type DEVICE

Other Intervention Names

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Fx CorDiax 80 dialyzer

Eligibility Criteria

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Inclusion Criteria

* Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
* 18 years old and older
* Creatinine clearance of more than 2 ml/min
* Agreement to participate in the clinical study
* Vascular access by arteriovenous fistula/graft

Exclusion Criteria

* Plan for kidney transplantation within 6 months
* Severe volume overloading state
* Dialysis through permanent catheter
* Any hematologic malignancy or monoclonal gammopathy
* Any malignancy
* Active infectious disease
* HIV infection
* Patient enrolled to another study within 3 month from starting the present study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role collaborator

Yeungnam University Hospital

OTHER

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-Lim Kim

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyungpook national university chilgok hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.

Reference Type BACKGROUND
PMID: 27587605 (View on PubMed)

Lim JH, Seo YJ, Jeon Y, Jeon YH, Jung HY, Choi JY, Park SH, Kim CD, Kang SH, Ryu JH, Kang DH, Cho JH, Kim YL. Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Mar 4;36(8):1614-1625. doi: 10.1681/ASN.0000000655.

Reference Type DERIVED
PMID: 40036081 (View on PubMed)

Other Identifiers

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KNU-Theranova-01

Identifier Type: -

Identifier Source: org_study_id

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