In Vivo Evaluation of the Nipro Elisio™ Dialyzer

• pre-dialytic serum beta-2 microglobulin level [ Time Frame: Month 1 (after one month) ] [ Designated as safety issue: No ]
  

• reduction rate of low molecular weight solutes (urea and creatinine) [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• dialysis dose (urea KT/V) [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• instantaneous clearance of low molecular weight solutes (urea and creatinine) [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• inflammatory markers (CRP, fibrinogen, orosomucoide) [ Time Frame: month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• inflammatory marker (interkeukin 6) [ Time Frame: month 0, 4 ] [ Designated as safety issue: No ]
  
• nutritional status (albumin, transthyretin, homocysteine) [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• endothelial progenitor cells [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• inflammatory mononuclear cell activation [ Time Frame: Month 0, 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  
• kappa and lambda light chains [ Time Frame: Month 0, 4 ] [ Designated as safety issue: No ]
  
• oxidative stress parameters (superoxide anion, AOPPs, AGEs) [ Time Frame: Month 0, 4 ] [ Designated as safety issue: No ]
  
• coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII) [ Time Frame: Month 0, 4 ] [ Designated as safety issue: No ]
  
• apoptosis markers (soluble FAS and FAS ligand) [ Time Frame: Month 0, 4 ] [ Designated as safety issue: No ]
  
• bone markers (bone PAL, Cross Laps, TRAP5b) [ Time Frame: Month 0, 4 ] [ Designated as safety issue: No ]
  

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.