In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Not Applicable

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01653808
• Lead Sponsor: Nipro Europe N.V.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2008-11
• Study Start: 2009-04
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pre-dialytic serum beta-2 microglobulin level	Month 1 (after one month)

Secondary Outcome Measures

Name	Time	Method
reduction rate of low molecular weight solutes (urea and creatinine)	Month 0, 1, 2, 3, 4
dialysis dose (urea KT/V)	Month 0, 1, 2, 3, 4
instantaneous clearance of low molecular weight solutes (urea and creatinine)	Month 0, 1, 2, 3, 4
inflammatory markers (CRP, fibrinogen, orosomucoide)	month 0, 1, 2, 3, 4
inflammatory marker (interkeukin 6)	month 0, 4
nutritional status (albumin, transthyretin, homocysteine)	Month 0, 1, 2, 3, 4
endothelial progenitor cells	Month 0, 1, 2, 3, 4
inflammatory mononuclear cell activation	Month 0, 1, 2, 3, 4
kappa and lambda light chains	Month 0, 4
oxidative stress parameters (superoxide anion, AOPPs, AGEs)	Month 0, 4
coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)	Month 0, 4
apoptosis markers (soluble FAS and FAS ligand)	Month 0, 4
bone markers (bone PAL, Cross Laps, TRAP5b)	Month 0, 4

Trial Locations

Locations (1)

University Hospital Center; 🇫🇷 Montpellier, France