Clinical trial NCT01653808: In Vivo Evaluation of the Nipro Elisio™ Dialyzer
Official title: In Vivo Evaluation of the Nipro Elisio™ Dialyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: CKD dialysis
hemodialysis
hemodiafiltration
Elisio dialyzer
efficacy
biocompatibility
Lead sponsor: Nipro Europe N.V.
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pre-dialytic serum beta-2 microglobulin level
timeFrame: Month 1 (after one month)
Secondary outcomes:
measure: reduction rate of low molecular weight solutes (urea and creatinine)
timeFrame: Month 0, 1, 2, 3, 4
measure: dialysis dose (urea KT/V)
timeFrame: Month 0, 1, 2, 3, 4
measure: instantaneous clearance of low molecular weight solutes (urea and creatinine)
timeFrame: Month 0, 1, 2, 3, 4
measure: inflammatory markers (CRP, fibrinogen, orosomucoide)
timeFrame: month 0, 1, 2, 3, 4
measure: inflammatory marker (interkeukin 6)
timeFrame: month 0, 4
measure: nutritional status (albumin, transthyretin, homocysteine)
timeFrame: Month 0, 1, 2, 3, 4
measure: endothelial progenitor cells
timeFrame: Month 0, 1, 2, 3, 4
measure: inflammatory mononuclear cell activation
timeFrame: Month 0, 1, 2, 3, 4
measure: kappa and lambda light chains
timeFrame: Month 0, 4
measure: oxidative stress parameters (superoxide anion, AOPPs, AGEs)
timeFrame: Month 0, 4
measure: coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)
timeFrame: Month 0, 4
measure: apoptosis markers (soluble FAS and FAS ligand)
timeFrame: Month 0, 4
measure: bone markers (bone PAL, Cross Laps, TRAP5b)
timeFrame: Month 0, 4
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Center
Study officials:
affiliation: University Hospital Center of Montpellier, France
name: Bernard CANAUD, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: