In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Nipro

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Device: Elisio-210H; Procedure: on line hemodiafiltration; Procedure: conventional hemodialysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01653808

Nipro-Elisio 210H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Elisio-210H with HD

Experimental group

Description:

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

Treatment:

Procedure: conventional hemodialysis

Device: Elisio-210H

Elisio-210H with on line HDF

Active Comparator group

Description:

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

Treatment:

Procedure: on line hemodiafiltration

Device: Elisio-210H