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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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Device: ELISIO dialyzer
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:
  • solute clearances [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ELISIO dialyzer
    3 x week dialysis using ELISIO dialyzer for 12 weeks
    Other Name: ELISIO dialyzer
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042327

Locations
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Investigators
Principal Investigator: andrew davenport, md center for nephrology, University college Hospital medical School
  More Information

No publications provided by Royal Free Hampstead NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A Davenport, Center for nephrology, University College London Medical School
ClinicalTrials.gov Identifier: NCT01042327     History of Changes
Other Study ID Numbers: 08/H0724/11
Study First Received: January 4, 2010
Last Updated: January 4, 2010
Health Authority: England: Medicines Regulatory Health Authority, Royal National Orthopaedic hospital ethics committee

Keywords provided by Royal Free Hampstead NHS Trust:
solute clearances

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013