Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

This study has been completed.
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT01042327
First received: January 4, 2010
Last updated: NA
Last verified: February 2009
History: No changes posted

January 4, 2010
January 4, 2010
February 2009
November 2009   (final data collection date for primary outcome measure)
solute clearances [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • erythropoietin requirements [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • effect on inflammatory markers [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • clotting potential [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer
Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
Device: ELISIO dialyzer
3 x week dialysis using ELISIO dialyzer for 12 weeks
Other Name: ELISIO dialyzer
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01042327
08/H0724/11
No
A Davenport, Center for nephrology, University College London Medical School
Royal Free Hampstead NHS Trust
Not Provided
Principal Investigator: andrew davenport, md center for nephrology, University college Hospital medical School
Royal Free Hampstead NHS Trust
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP