In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Chronic Kidney Disease Clinical Trial

Official title:

In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653808
• Other study ID #: Nipro-Elisio 210H
• Status: Completed
• Phase: N/A
• First received: July 27, 2012
• Last updated: September 13, 2012
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2008
• Source: Nipro Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

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

Locations

Country	Name	City	State
France	University Hospital Center	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Nipro Europe N.V.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre-dialytic serum beta-2 microglobulin level		Month 1 (after one month)	No
Secondary	reduction rate of low molecular weight solutes (urea and creatinine)		Month 0, 1, 2, 3, 4	No
Secondary	dialysis dose (urea KT/V)		Month 0, 1, 2, 3, 4	No
Secondary	instantaneous clearance of low molecular weight solutes (urea and creatinine)		Month 0, 1, 2, 3, 4	No
Secondary	inflammatory markers (CRP, fibrinogen, orosomucoide)		month 0, 1, 2, 3, 4	No
Secondary	inflammatory marker (interkeukin 6)		month 0, 4	No
Secondary	nutritional status (albumin, transthyretin, homocysteine)		Month 0, 1, 2, 3, 4	No
Secondary	endothelial progenitor cells		Month 0, 1, 2, 3, 4	No
Secondary	inflammatory mononuclear cell activation		Month 0, 1, 2, 3, 4	No
Secondary	kappa and lambda light chains		Month 0, 4	No
Secondary	oxidative stress parameters (superoxide anion, AOPPs, AGEs)		Month 0, 4	No
Secondary	coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)		Month 0, 4	No
Secondary	apoptosis markers (soluble FAS and FAS ligand)		Month 0, 4	No
Secondary	bone markers (bone PAL, Cross Laps, TRAP5b)		Month 0, 4	No