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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Device: ELISIO-15H
* Device: Revaclear
* Device: Optiflux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solute Clearance<br>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<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: dialyzer;Device: Revaclear<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;Device: Optiflux<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;|
| Active Comparator: Hemocompatibility<br>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<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: dialyzer;Device: Revaclear<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;Device: Optiflux<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;|
| Active Comparator: Solute removal rate<br>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<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: dialyzer;Device: Revaclear<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;Device: Optiflux<br>* Each patient to undergo 3 successive hemodialysis/week with this dialyzer.<br>* Other names: Dialyzer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |