A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
August 5, 2022
CompletedAugust 5, 2022
August 1, 2022
2.5 years
December 16, 2014
October 29, 2019
August 3, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Clearance and Solute Removal Characteristics of Dialyzers
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. Dialyzer clearance is calculated as follows: 60 minute clearance:(((\[S\]60'Art - \[S\]60'Ven) / \[S\]60'Art) \* Qb) where \[S\] = solute concentration; Qb = blood flow rate. S
During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.
Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers
The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.
Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.
Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.
Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers.
Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis..
Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers.
Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.
Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers.
Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis.
Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers.
Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.
Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers.
Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.
Study Arms (3)
Solute Clearance
ACTIVE COMPARATORSolute 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.
Hemocompatibility
ACTIVE COMPARATORHemocompatibility 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 ..
Solute removal rate
ACTIVE COMPARATORSolute (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
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Missouri-Columbialead
- Nipro Medical Corporationcollaborator
- Dialysis Clinic, Inc.collaborator
Study Sites (1)
Dialysis Clinic Incorporated
Columbia, Missouri, 65201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Madhukar Misra, MD
- Organization
- University of Missouri, Department of Medicine, Division of Nephrology
Study Officials
- PRINCIPAL INVESTIGATOR
Madhukar Misra, MD
University of Missouri-Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical medicine
Study Record Dates
First Submitted
December 16, 2014
First Posted
May 4, 2015
Study Start
June 1, 2015
Primary Completion
November 30, 2017
Study Completion
August 31, 2018
Last Updated
August 5, 2022
Results First Posted
August 5, 2022
Record last verified: 2022-08