Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Chronic Kidney Disease Clinical Trial

Official title:

Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042327
• Other study ID #: 08/H0724/11
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2010
• Last updated: September 14, 2015
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2009
• Source: Royal Free Hampstead NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• ELISIO dialyzer
3 x week dialysis using ELISIO dialyzer for 12 weeks
• Fresenius FX100 dialyzer

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hampstead NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	solute clearances		9 months	No
Secondary	erythropoietin requirements		9 months	No
Secondary	effect on inflammatory markers		9 months	No
Secondary	clotting potential		9 months	Yes