Columbia, Missouri 65201

  • End Stage Renal Disease (ESRD)

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

2002150


NCT ID:

NCT02433210


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Madhukar Misra, MD
Principal Investigator
University of Missouri-Columbia
Primary Contact:MADHUKAR MISRA, MD
5738827992
misram@health.missouri.edu
Backup Contact:HAROLD MOORE, MA
5738824433
mooreh@health.missouri.edu

Study Dates

Start Date:June 2015
Completion Date:May 2017
Completion Type:Anticipated
Primary Completion Date:May 2017
Primary Completion Type:Anticipated
Verification Date:December 2016
Last Changed Date:December 20, 2016
First Received Date:December 16, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Clotted fibers in the dialyzer
Time Frame:After each of the three 240 minute dialysis session each week for three weeks.
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure: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 int
Safety Issues:False
Description:The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.
Outcome Type:Primary Outcome
Measure: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 t
Safety Issues:False
Description: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, c

Study Interventions

Intervention Type:Device
Name:Optiflux
Description:Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Arm Name:Solute Clearance
Other Name:Dialyzer
Intervention Type:Device
Name:Revaclear
Description:Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Arm Name:Solute Clearance
Other Name:Dialyzer
Intervention Type:Device
Name:ELISIO-15H
Description:Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Arm Name:Solute Clearance
Other Name:dialyzer

Study Arms

Study Arm Type:Active Comparator
Arm Name:Solute removal rate
Description: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 .
Study Arm Type:Active Comparator
Arm Name:Hemocompatibility
Description: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 ..
Study Arm Type:Active Comparator
Arm Name:Solute Clearance
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia
Agency Class:Other
Agency Type:Collaborator
Agency Name:Nipro Medical Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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