Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

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

2018-03-15

Study Completion Date

2020-08-31

Brief Summary

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Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.

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Detailed Description

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While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.

Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.

With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.

Conditions

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Kidney Failure, Chronic Renal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Exploratory, Multicenter, Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Extended HD with MCO dialyzer

Group Type EXPERIMENTAL

Theranova

Intervention Type DEVICE

Extended HD with theranova

Control group

Online hemodiafiltration

Group Type ACTIVE_COMPARATOR

Online hemodiafiltration

Intervention Type DEVICE

Online hemodiafiltration

Interventions

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Theranova

Extended HD with theranova

Intervention Type DEVICE

Online hemodiafiltration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years old and older
* Hemodialysis more than 3 months because of end-stage renal disease
* Consent to the study protocol

Exclusion Criteria

* Already receiving online hemodiafiltration before study enrollment
* Dialysis schedule other than three times per week (e.g., once per week)
* Receiving concurrent peritoneal dialysis
* Having a plan to receive kidney transplantation within 1 year
* Having multiple myeloma or monoclonal gammopathy
* Having advanced or active malignancy
* Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
* Participating in other clinical trials

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No