In Vivo Evaluation of the Nipro Elisio™ Dialyzer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nipro Europe N.V.
ClinicalTrials.gov Identifier:
NCT01653808
First received: July 27, 2012
Last updated: September 13, 2012
Last verified: November 2008
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Device: Elisio-210H
Procedure: conventional hemodialysis
Procedure: on line hemodiafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Resource links provided by NLM:


Further study details as provided by Nipro Europe N.V.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elisio-210H with HD
hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer
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
Active Comparator: Elisio-210H with on line HDF
hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer
Device: Elisio-210H
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
Procedure: on line hemodiafiltration
comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653808

Locations
France
University Hospital Center
Montpellier, France, 34295
Sponsors and Collaborators
Nipro Europe N.V.
Investigators
Principal Investigator: Bernard CANAUD, MD, Prof. University Hospital Center of Montpellier, France
  More Information

No publications provided

Responsible Party: Nipro Europe N.V.
ClinicalTrials.gov Identifier: NCT01653808     History of Changes
Other Study ID Numbers: Nipro-Elisio 210H
Study First Received: July 27, 2012
Last Updated: September 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Nipro Europe N.V.:
CKD dialysis
hemodialysis
hemodiafiltration
Elisio dialyzer
efficacy
biocompatibility

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014