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In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Elisio-210H
conventional hemodialysis
on line hemodiafiltration
Sponsored by
Nipro Europe N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elisio-210H with HD

Elisio-210H with on line HDF

Arm Description

hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer

hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer

Outcomes

Primary Outcome Measures

pre-dialytic serum beta-2 microglobulin level

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2012
Last Updated
September 13, 2012
Sponsor
Nipro Europe N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01653808
Brief Title
In Vivo Evaluation of the Nipro Elisio™ Dialyzer
Official Title
In Vivo Evaluation of the Nipro Elisio™ Dialyzer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nipro Europe N.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elisio-210H with HD
Arm Type
Experimental
Arm Description
hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer
Arm Title
Elisio-210H with on line HDF
Arm Type
Active Comparator
Arm Description
hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer
Intervention Type
Device
Intervention Name(s)
Elisio-210H
Intervention Description
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
Intervention Type
Procedure
Intervention Name(s)
conventional hemodialysis
Intervention Description
comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
Intervention Type
Procedure
Intervention Name(s)
on line hemodiafiltration
Intervention Description
comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer
Primary Outcome Measure Information:
Title
pre-dialytic serum beta-2 microglobulin level
Time Frame
Month 1 (after one month)
Secondary Outcome Measure Information:
Title
reduction rate of low molecular weight solutes (urea and creatinine)
Time Frame
Month 0, 1, 2, 3, 4
Title
dialysis dose (urea KT/V)
Time Frame
Month 0, 1, 2, 3, 4
Title
instantaneous clearance of low molecular weight solutes (urea and creatinine)
Time Frame
Month 0, 1, 2, 3, 4
Title
inflammatory markers (CRP, fibrinogen, orosomucoide)
Time Frame
month 0, 1, 2, 3, 4
Title
inflammatory marker (interkeukin 6)
Time Frame
month 0, 4
Title
nutritional status (albumin, transthyretin, homocysteine)
Time Frame
Month 0, 1, 2, 3, 4
Title
endothelial progenitor cells
Time Frame
Month 0, 1, 2, 3, 4
Title
inflammatory mononuclear cell activation
Time Frame
Month 0, 1, 2, 3, 4
Title
kappa and lambda light chains
Time Frame
Month 0, 4
Title
oxidative stress parameters (superoxide anion, AOPPs, AGEs)
Time Frame
Month 0, 4
Title
coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)
Time Frame
Month 0, 4
Title
apoptosis markers (soluble FAS and FAS ligand)
Time Frame
Month 0, 4
Title
bone markers (bone PAL, Cross Laps, TRAP5b)
Time Frame
Month 0, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard CANAUD, MD, Prof.
Organizational Affiliation
University Hospital Center of Montpellier, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Center
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

In Vivo Evaluation of the Nipro Elisio™ Dialyzer

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