NCT01042327

Brief Summary

Today, haemodialysis is a recognized standard treatment for patients with chronic kidney disease stage 5. During the haemodialysis treatment session, blood passes from the patient through the extracorporeal circuit and is then returned. The dialyzer represents the greatest surface are of the extracorporeal circuit, as dialysis treatment is essentially based on the removal of small molecular weight solutes down along a concentration gradient, and this depends upon surface area. The ELISIO-H dialyzer differs in design to our current standard dialyzer, the FX100, by having fibers of a greater internal diameter, which potentially allows more internal haemofiltration, leading to an improved clearance of larger molecular weight solutes. It is now thought that these so called "middle molecular weight" solutes are more important in contributing to the clinical condition termed azotaemia, rather than smaller solutes such as urea. The investigators therefore wish to study the clearance of middle sized molecules between the different dialyzers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

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

February 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
Last Updated

September 15, 2015

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

January 4, 2010

Last Update Submit

September 14, 2015

Conditions

Chronic Kidney Disease

Keywords

solute clearances

Outcome Measures

Primary Outcomes (1)

  • solute clearances

    9 months

Secondary Outcomes (3)

  • erythropoietin requirements

    9 months

  • effect on inflammatory markers

    9 months

  • clotting potential

    9 months

Study Arms (1)

dialyzer comparison

EXPERIMENTAL

Stable chronic kidney dialysis patients, currently dialyzing on the main Royal Free hospital dialysis unit will be asked to participate in the study. It is aimed to recruit 15 patients currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone membranes for \> 3 months. During a mid week dialysis session, dialysis adequacy will be assessed by on line clearance, and samples of both blood and dialysate taken to assess, both clearances and bio-compatibility. Thereafter patients would be switched to dialyse using the ELISIOTM-H dialyzer, but continue with the same dialysis prescription, and after 3 months, measurements repeated

Device: ELISIO dialyzerDevice: Fresenius FX100 dialyzer

Interventions

ELISIO dialyzerDEVICE

3 x week dialysis using ELISIO dialyzer for 12 weeks

Also known as: ELISIOTM-H dialyzer
dialyzer comparison
Fresenius FX100 dialyzerDEVICE
dialyzer comparison

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone membranes for \> 3 months, who are stable and able to provide informed consent.

You may not qualify if:

  • using other dialyzers, unable to provide informed consent, unstable on dialysis or have problematical vascular access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

  • Vernon K, Peasegood J, Riddell A, Davenport A. Dialyzers designed to increase internal filtration do not result in significantly increased platelet activation and thrombin generation. Nephron Clin Pract. 2011;117(4):c403-8. doi: 10.1159/000319884. Epub 2010 Nov 12.

    PMID: 21071966DERIVED

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

  • andrew davenport, md

    center for nephrology, University college Hospital medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 15, 2015

Record last verified: 2009-02

Locations

GB(1)