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A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT02433210
Recruitment Status : Unknown
Verified July 2017 by Madhukar Misra, University of Missouri-Columbia.
Recruitment status was:  Recruiting
First Posted : May 4, 2015
Last Update Posted : July 11, 2017
Sponsor:
Collaborators:
Nipro Medical Corporation
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Madhukar Misra, University of Missouri-Columbia

Brief Summary:

The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.

10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Device: ELISIO-15H Device: Revaclear Device: Optiflux Not Applicable

Detailed Description:
Current patients receiving dialysis treatment for end stage renal disease and who meet the inclusion/exclusion criteria will be entered into the study. These patients will continue on their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each patient will be studied for three weeks with each week starting with a dialyzer of a different manufacture but of comparable characteristics. Solute clearances and removal will be determined at each of the three dialysis sessions during the week. During session 2 of each week additional specimens will be taken to analyze for hemocompatibility. At the end of the study all clearances and the hemocompatibility markers for each dialyzer will be compared to one another as well as to the manufactures stated characteristics. Blood for the clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Basic Science
Official Title: A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers
Study Start Date : June 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Solute Clearance
Solute clearance at 60 minutes for urea, creatinine, phosphate, beta 2 microglobulin, and myoglobin will be determined three times for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers at the 60 minute time point.
Device: ELISIO-15H
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: dialyzer

Device: Revaclear
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer

Device: Optiflux
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer

Active Comparator: Hemocompatibility
Hemocompatibility will be determined using the markers C3a, C5a, thrombin/anti-thrombin complex and complete blood count with platelets will be determined one time for each dialyzer at session 2 and at time points 0, 15, 30, 60, and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers ..
Device: ELISIO-15H
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: dialyzer

Device: Revaclear
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer

Device: Optiflux
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer

Active Comparator: Solute removal rate
Solute (urea, creatinine, phosphate, beta 2 macroglobulin, and myoglobin) removal rate will be determined time points 0 and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers .
Device: ELISIO-15H
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: dialyzer

Device: Revaclear
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer

Device: Optiflux
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other Name: Dialyzer




Primary Outcome Measures :
  1. Clearance and solute removal characteristics of dialyzers [ Time Frame: During each of the three dialysis sessions per week at the 60 minute and 240 minute time point for three weeks. ]
    Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Solute removal rate over the 240 minutes will also be calculated for urea, creatinine, beta 2 microglobulin, phosphate and myoglobin.

  2. Hemocompatibility characteristics of dialyzers [ Time Frame: Once a week during the second of the three weekly sessions at 0, 15, 30, 60 and 240 minutes time intervals. ]
    The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.


Secondary Outcome Measures :
  1. Clotted fibers in the dialyzer [ Time Frame: After each of the three 240 minute dialysis session each week for three weeks. ]
    After the rinse-back procedure the dialyzer will be to the laboratory and photographed and the heads removed with photos taken of the head spaces. The case will then be removed and the fibers cut from the potting material and clotted fibers counted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESRD patients 18 years or older
  • Stable on hemodialysis for more than 3 months
  • Stable hemoglobin between 11-12 g/dl
  • Stable arteriovenous (AV) fistula vascular access
  • Stable anticoagulation and ESA regimen
  • No active infection
  • Able to sign informed consent and able to participate in the study
  • Medically stable

Exclusion Criteria:

  • Participation in another study which may interfere with the planned study
  • Active infection
  • Medical conditions which may interfere with the study (cardiac, liver disease, Hepatitis)
  • Allergy to dialyzer membrane materials e.g. polysulfone
  • Patients which cannot tolerate Heparin
  • Female who are pregnant or planning to be pregnant
  • Problem with or allergy to anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433210


Contacts
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Contact: MADHUKAR MISRA, MD 5738827992 misram@health.missouri.edu
Contact: HAROLD MOORE, MA 5738824433 mooreh@health.missouri.edu

Locations
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United States, Missouri
Dialysis Clinic Incorporated Recruiting
Columbia, Missouri, United States, 65201
Contact: Maduhkar Misra, MD    573-882-7992    misram@health.missouri.edu   
Contact: Harold Moore    573 882-4433    MooreH@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Nipro Medical Corporation
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: Madhukar Misra, MD University of Missouri-Columbia
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Responsible Party: Madhukar Misra, Professor of Clinical medicine, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02433210    
Other Study ID Numbers: 2002150
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency