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In Vivo Evaluation of the Nipro Elisio™ Dialyzer

NCT ID: NCT01653808

Last Updated: 2012-09-14

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

Detailed Description

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Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

Conditions

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Chronic Kidney Disease

Keywords

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CKD dialysis hemodialysis hemodiafiltration Elisio dialyzer efficacy biocompatibility

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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Elisio-210H with HD

hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer

Group Type EXPERIMENTAL

Elisio-210H

Intervention Type DEVICE

comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration

conventional hemodialysis

Intervention Type PROCEDURE

comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer

Elisio-210H with on line HDF

hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer

Group Type ACTIVE_COMPARATOR

Elisio-210H

Intervention Type DEVICE

comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration

on line hemodiafiltration

Intervention Type PROCEDURE

comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

Interventions

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Elisio-210H

comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration

Intervention Type DEVICE

conventional hemodialysis

comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer

Intervention Type PROCEDURE

on line hemodiafiltration

comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* CKD dialysis patients on treatment with three times a week HD for more than three months
* with a stable anticoagulation scheme
* with haemoglobin level \>10.5 g/dL
* with vascular access allowing a stable blood flow of 300 mL/min during treatment

Exclusion Criteria

* patient already enrolled in another study
* pregnancy
* symptoms or signs of acute/chronic inflammatory or infectious diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nipro Europe N.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard CANAUD, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Montpellier, France

Locations

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University Hospital Center

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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Nipro-Elisio 210H

Identifier Type: -

Identifier Source: org_study_id