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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

Tracking Information
First Submitted Date  ICMJE December 16, 2014
First Posted Date  ICMJE May 4, 2015
Last Update Posted Date July 11, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
Official Title  ICMJE A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Basic Science
Condition  ICMJE End Stage Renal Disease (ESRD)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: ELISIO-15H
    • Device: Revaclear
    • Device: Optiflux
  • 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 ..
    Interventions:
    • Device: ELISIO-15H
    • Device: Revaclear
    • Device: Optiflux
  • 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 .
    Interventions:
    • Device: ELISIO-15H
    • Device: Revaclear
    • Device: Optiflux
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2015)
10
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02433210
Other Study ID Numbers  ICMJE 2002150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Madhukar Misra, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE
  • Nipro Medical Corporation
  • Dialysis Clinic, Inc.
Investigators  ICMJE
Principal Investigator: Madhukar Misra, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date July 2017

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