Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2022-03-31

Brief Summary

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study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Approximately 700 patients will be included.

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Detailed Description

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This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

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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expanded hemodialysis (HDx)

HDx therapies 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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

A medium cut-off dialyzer used for HDx 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

online hemodiafiltration (HDF-OL)

OL-HDF therapies 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

Group Type ACTIVE_COMPARATOR

A synthetic high-flux dialyzer will be used for OL-HDF.

Intervention Type DEVICE

A synthetic high-flux dialyzer used for OL-HDF 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

Interventions

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A synthetic high-flux dialyzer will be used for OL-HDF.

A synthetic high-flux dialyzer used for OL-HDF 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

Intervention Type DEVICE

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

A medium cut-off dialyzer used for HDx 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* End stage Renal Disease (ESRD) patients
* Age\> 18 years old
* HD therapy three times per week for 3 months at least and a maximum of 24 months.

Exclusion Criteria

* No informed consent provided
* Synthetic membrane allergy
* Pregnant, breastfeeding, or planning to become pregnant
* Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment.
* Scheduled for living-donor transplantation within the study period
* Patients with a significant residual renal function (defined as Urea clearance \>2,5 ml/min.
* Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No