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Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01042327
Enrollment
15
Registered
2010-01-05
Start date
2009-02-28
Completion date
2009-11-30
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

solute clearances

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.

Detailed description

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 Assessments Primary Clearances : on-line Kt/V, dual pool Kt/V, phosphate, b2microglobulin, cystatin C Secondary Serum :isoprostane generation complement activation platelet activation - coagulation activation - thrombophilic markers - Other Anticoagulation requirements & clotted circuits erythropoietin requirements, phosphate control therapy CRP

Interventions

DEVICEELISIO dialyzer

3 x week dialysis using ELISIO dialyzer for 12 weeks

DEVICEFresenius FX100 dialyzer

Sponsors

Royal Free Hampstead NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 15 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
solute clearances9 months

Secondary

MeasureTime frame
erythropoietin requirements9 months
effect on inflammatory markers9 months
clotting potential9 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026