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Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

NCT01042327 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-09-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ELISIO dialyzer

3 x week dialysis using ELISIO dialyzer for 12 weeks

DEVICE

Fresenius FX100 dialyzer

Sponsors & Collaborators

  • Royal Free Hampstead NHS Trust

    lead OTHER

Principal Investigators

  • andrew davenport, md · center for nephrology, University college Hospital medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042327 on ClinicalTrials.gov