NCT01653808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 14, 2012

Status Verified

November 1, 2008

Enrollment Period

3.4 years

First QC Date

July 27, 2012

Last Update Submit

September 13, 2012

Conditions

Chronic Kidney Disease

Keywords

CKD dialysishemodialysishemodiafiltrationElisio dialyzerefficacybiocompatibility

Outcome Measures

Primary Outcomes (1)

  • pre-dialytic serum beta-2 microglobulin level

    Month 1 (after one month)

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Elisio-210H with HD

EXPERIMENTAL

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

Device: Elisio-210HProcedure: conventional hemodialysis

Elisio-210H with on line HDF

ACTIVE COMPARATOR

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

Device: Elisio-210HProcedure: on line hemodiafiltration

Interventions

Elisio-210HDEVICE

comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration

Elisio-210H with HDElisio-210H with on line HDF
conventional hemodialysisPROCEDURE

comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer

Elisio-210H with HD
on line hemodiafiltrationPROCEDURE

comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

Elisio-210H with on line HDF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient already enrolled in another study
  • pregnancy
  • symptoms or signs of acute/chronic inflammatory or infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Center

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bernard CANAUD, MD, Prof.

    University Hospital Center of Montpellier, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

April 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 14, 2012

Record last verified: 2008-11

Locations

FR(1)