End Stage Renal Disease (ESRD)
Conditions
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.
Interventions
DEVICEELISIO-15H
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
DEVICERevaclear
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
DEVICEOptiflux
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Sponsors
Nipro Medical Corporation
Dialysis Clinic, Inc.
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance and Solute Removal Characteristics of Dialyzers | 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. | 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 |
| Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 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. | The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets. |
| Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis 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.. | Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers. |
| Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis 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. | Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers. |
| Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis 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. | Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers. |
| Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis 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. | Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers. |
| Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis 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. | Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers. |
Countries
United States
Participant flow
Recruitment details
Patients were pre-screened to determine if met inclusion/exclusion criteria by the study coordinator. If they met the criteria the primary investigator met with them explained the project and if interested he then consented them. Once consented the patient started the study on the following Monday.
Pre-assignment details
There were no significant events. We didn't lose any consented patients prior to starting the study. There was no special preparation prior to start of study other than inclusion/exclusion criteria which took place prior to consent.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: ELISIO, Then Revaclear, Then Optiflux This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. | 4 |
| Experimental: Revaclear, Then Optiflux, Then ELISIO This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. | 3 |
| Experimental: Optiflux, Then ELISIO, Then Revaclear This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Experimental: Revaclear, Then Optiflux, Then ELISIO | Experimental: Optiflux, Then ELISIO, Then Revaclear | Total | Experimental: ELISIO, Then Revaclear, Then Optiflux |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 3 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 7 Participants | 2 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 3.9 | 56.3 years STANDARD_DEVIATION 7.8 | 57.2 years STANDARD_DEVIATION 10.91 | 60.5 years STANDARD_DEVIATION 14.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 10 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BUN Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 331.9 milliliters per minute (ml/min) | Standard Deviation 62.9 |
| BUN Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 336.2 milliliters per minute (ml/min) | Standard Deviation 57.4 |
| BUN Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 354.1 milliliters per minute (ml/min) | Standard Deviation 48 |
| BUN Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 352.8 milliliters per minute (ml/min) | Standard Deviation 40.1 |
| BUN Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 318.8 milliliters per minute (ml/min) | Standard Deviation 69.4 |
| BUN Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 340.4 milliliters per minute (ml/min) | Standard Deviation 72.5 |
| BUN Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 361.8 milliliters per minute (ml/min) | Standard Deviation 51 |
| BUN Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 355.7 milliliters per minute (ml/min) | Standard Deviation 58.3 |
| BUN Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 356.3 milliliters per minute (ml/min) | Standard Deviation 44.1 |
| Creatinine Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 256.7 milliliters per minute (ml/min) | Standard Deviation 78.6 |
| Creatinine Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 271.8 milliliters per minute (ml/min) | Standard Deviation 65.2 |
| Creatinine Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 277.8 milliliters per minute (ml/min) | Standard Deviation 59.2 |
| Creatinine Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 297.6 milliliters per minute (ml/min) | Standard Deviation 39.9 |
| Creatinine Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 295.9 milliliters per minute (ml/min) | Standard Deviation 53.7 |
| Creatinine Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 275.5 milliliters per minute (ml/min) | Standard Deviation 39.2 |
| Creatinine Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 293.4 milliliters per minute (ml/min) | Standard Deviation 37 |
| Creatinine Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 296.6 milliliters per minute (ml/min) | Standard Deviation 33.3 |
| Creatinine Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 298.4 milliliters per minute (ml/min) | Standard Deviation 49.3 |
| Phosphate Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 296.6 milliliters per minute (ml/min) | Standard Deviation 69.7 |
| Phosphate Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 309.8 milliliters per minute (ml/min) | Standard Deviation 71 |
| Phosphate Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 306.4 milliliters per minute (ml/min) | Standard Deviation 43 |
| Phosphate Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 324.8 milliliters per minute (ml/min) | Standard Deviation 60.5 |
| Phosphate Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 276.6 milliliters per minute (ml/min) | Standard Deviation 100.9 |
| Phosphate Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 324.7 milliliters per minute (ml/min) | Standard Deviation 45.3 |
| Phosphate Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 333.1 milliliters per minute (ml/min) | Standard Deviation 48.3 |
| Phosphate Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 277 milliliters per minute (ml/min) | Standard Deviation 90.3 |
| Phosphate Clearance Elisio | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 330.4 milliliters per minute (ml/min) | Standard Deviation 47.9 |
| Beta 2 Microglobulin Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 137.6 milliliters per minute (ml/min) | Standard Deviation 38.7 |
| Beta 2 Microglobulin Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 144 milliliters per minute (ml/min) | Standard Deviation 26.8 |
| Beta 2 Microglobulin Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 149.6 milliliters per minute (ml/min) | Standard Deviation 28 |
| Beta 2 Microglobulin Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 57.2 milliliters per minute (ml/min) | Standard Deviation 41.5 |
| Beta 2 Microglobulin Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 63 milliliters per minute (ml/min) | Standard Deviation 49.7 |
| Beta 2 Microglobulin Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 61.4 milliliters per minute (ml/min) | Standard Deviation 24.7 |
| Beta 2 Microglobulin ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 169.1 milliliters per minute (ml/min) | Standard Deviation 59.6 |
| Beta 2 Microglobulin ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 136.4 milliliters per minute (ml/min) | Standard Deviation 90.3 |
| Beta 2 Microglobulin ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 165.7 milliliters per minute (ml/min) | Standard Deviation 51.5 |
| Myoglobin Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | -2.6 milliliters per minute (ml/min) | Standard Deviation 26.4 |
| Myoglobin Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | -8.6 milliliters per minute (ml/min) | Standard Deviation 12.6 |
| Myoglobin Clearance Optiflux | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | -7.1 milliliters per minute (ml/min) | Standard Deviation 29 |
| Myoglobin Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 32.6 milliliters per minute (ml/min) | Standard Deviation 53.5 |
| Myoglobin Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 24.5 milliliters per minute (ml/min) | Standard Deviation 57.6 |
| Myoglobin Clearance Revaclear | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 62.1 milliliters per minute (ml/min) | Standard Deviation 108.2 |
| Myoglobin Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 2 | 19.1 milliliters per minute (ml/min) | Standard Deviation 64.3 |
| Myoglobin Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 3 | 45.5 milliliters per minute (ml/min) | Standard Deviation 40 |
| Myoglobin Clearance ELISIO | Clearance and Solute Removal Characteristics of Dialyzers | Session 1 | 33.4 milliliters per minute (ml/min) | Standard Deviation 47.4 |
Comparison: Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.p-value: <0.001t-test, 2 sided
Comparison: Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.p-value: <0.001t-test, 2 sided
Comparison: Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..p-value: =0.178t-test, 2 sided
Comparison: Session 1 Clearance of myoglobin Optiflux vs Revaclear.p-value: =0.016Wilcoxon (Mann-Whitney)
Comparison: Session 1 Clearance of myoglobin Optiflux vs ELISIO.p-value: =0.033t-test, 2 sided
Comparison: Session 1 Clearance of myoglobin Revaclear vs ELISIO.p-value: =0.935t-test, 2 sided
Comparison: Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.p-value: =0.463t-test, 2 sided
Comparison: Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.p-value: =0.392t-test, 2 sided
Comparison: Session 2 Clearance urea nitrogen Revaclear vs ELISIO.p-value: =0.597Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance of creatinine Optiflux vs Revaclear.p-value: =0.162Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance of creatinine Optiflux vs ELISIO.p-value: 0.186Wilcoxon (Mann-Whitney)
Comparison: Session 1 Urea nitrogen clearance Optiflux vs Revaclear.p-value: 0.624t-test, 2 sided
Comparison: Session 1 Urea nitrogen clearance Optiflux vs ELISIO.p-value: 0.732t-test, 2 sided
Comparison: Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.p-value: 0.427Wilcoxon (Mann-Whitney)
Comparison: Session 1 Creatinine clearance Optiflux vs Revaclear..p-value: 0.379t-test, 2 sided
Comparison: Session 1 Creatinine clearance Optiflux vs ELISIO.p-value: 0.318t-test, 2 sided
Comparison: Session 1 Creatinine clearance Revaclear vs ELISIO.p-value: =0.914t-test, 2 sided
Comparison: Session 1 Phosphate clearance Optiflux vs Revaclear.p-value: =0.623Wilcoxon (Mann-Whitney)
Comparison: Session 1 Phosphate clearance Optiflux vs ELISIO.p-value: =0.403t-test, 2 sided
Comparison: Session 1 Phosphate clearance Revaclear vs ELISIO.p-value: =0.85Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance of creatinine Revaclear vs ELISIO.p-value: =0.815t-test, 2 sided
Comparison: Session 2 Clearance of Phosphate Optiflux vs Revaclear.p-value: =0.367t-test, 2 sided
Comparison: Session 2 Clearance of phosphate Optiflux vs Elisio.p-value: =0.821Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance phosphate Revaclear vs ELISIO.p-value: =0.364Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.p-value: <0.001t-test, 2 sided
Comparison: Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.p-value: <0.001t-test, 2 sided
Comparison: Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.p-value: =0.254t-test, 2 sided
Comparison: Session 2 Clearance of myoglobin Optiflux vs Revaclear.p-value: =0.079t-test, 2 sided
Comparison: Session 2 Clearance of myoglobin Optiflux vs ELISIO.p-value: =0.086Wilcoxon (Mann-Whitney)
Comparison: Session 2 Clearance myoglobin Revaclear vs ELISIO.p-value: =0.888t-test, 2 sided
Comparison: Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.p-value: =0.663t-test, 2 sided
Comparison: Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.p-value: =0.391t-test, 2 sided
Comparison: Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.p-value: =0.214t-test, 2 sided
Comparison: Session 3 Clearance of creatinine Optiflux vs Revaclear.p-value: =0.918t-test, 2 sided
Comparison: Session 3 Clearance of creatinine Optiflux vs ELISIO.p-value: =0.394t-test, 2 sided
Comparison: Session 3 Clearance of creatinine Revaclear vs ELISIO.p-value: =0.211t-test, 2 sided
Comparison: Session 3 Clearance of phosphate Optiflux vs ELISIO.p-value: =0.222t-test, 2 sided
Comparison: Session 3 Clearances of phosphate Revaclear vs ELISIO.p-value: =0.162Wilcoxon (Mann-Whitney)
Comparison: Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.p-value: <0.001t-test, 2 sided
Comparison: Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.p-value: =0.025Wilcoxon (Mann-Whitney)
Comparison: Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.p-value: =0.903Wilcoxon (Mann-Whitney)
Comparison: Session 3 Clearances of myoglobin Optiflux vs Revaclear.p-value: =0.003Wilcoxon (Mann-Whitney)
Comparison: Session 3 Clearance of myoglobin Optiflux vs ELISIO.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Session 3 Clearance of myoglobin Revaclear vs ELISIO.p-value: =0.472Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 8.5 Percent change from baseline | Standard Deviation 28 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -5.1 Percent change from baseline | Standard Deviation 26.8 |
| BUN Clearance Elisio | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -4.5 Percent change from baseline | Standard Deviation 15.4 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 11.2 Percent change from baseline | Standard Deviation 17.8 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 7.5 Percent change from baseline | Standard Deviation 25.3 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -1.1 Percent change from baseline | Standard Deviation 19.6 |
| Phosphate Clearance Optiflux | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -17.7 Percent change from baseline | Standard Deviation 22.8 |
| Phosphate Clearance Revaclear | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -9.8 Percent change from baseline | Standard Deviation 22.7 |
| Phosphate Clearance Elisio | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -6.1 Percent change from baseline | Standard Deviation 35.4 |
| Beta 2 Microglobulin Revaclear | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 15.9 Percent change from baseline | Standard Deviation 15.6 |
| Beta 2 Microglobulin Optiflux | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | -6.6 Percent change from baseline | Standard Deviation 14.3 |
| Beta 2 Microglobulin ELISIO | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | 1 Percent change from baseline | Standard Deviation 31.7 |
p-value: =0.216t-test, 2 sided
p-value: =0.216t-test, 2 sided
p-value: =0.952t-test, 2 sided
p-value: =0.714t-test, 2 sided
p-value: =0.156t-test, 2 sided
p-value: =0.427t-test, 2 sided
Comparison: No significant differencep-value: =0.487t-test, 2 sided
Comparison: No significant differencep-value: =0.111Wilcoxon (Mann-Whitney)
Comparison: No significant differencep-value: =0.198Wilcoxon (Mann-Whitney)
Comparison: Showed a significant differencep-value: =0.007t-test, 2 sided
Comparison: No significant differencep-value: =0.202t-test, 2 sided
Comparison: No significant differencep-value: =0.54t-test, 2 sided
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -5.8 Percent change from baseline. | Standard Deviation 6.2 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.2 Percent change from baseline. | Standard Deviation 6.1 |
| BUN Clearance Elisio | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -4.2 Percent change from baseline. | Standard Deviation 4.4 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.8 Percent change from baseline. | Standard Deviation 3.7 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.1 Percent change from baseline. | Standard Deviation 5.3 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.0 Percent change from baseline. | Standard Deviation 5.6 |
| Phosphate Clearance Optiflux | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.8 Percent change from baseline. | Standard Deviation 4 |
| Phosphate Clearance Revaclear | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.0 Percent change from baseline. | Standard Deviation 6.7 |
| Phosphate Clearance Elisio | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 0.03 Percent change from baseline. | Standard Deviation 5.6 |
| Beta 2 Microglobulin Revaclear | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 0.8 Percent change from baseline. | Standard Deviation 7 |
| Beta 2 Microglobulin Optiflux | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 1.9 Percent change from baseline. | Standard Deviation 6.5 |
| Beta 2 Microglobulin ELISIO | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 2.0 Percent change from baseline. | Standard Deviation 8.3 |
p-value: =0.376t-test, 2 sided
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.713Wilcoxon (Mann-Whitney)
p-value: =0.424t-test, 2 sided
p-value: =0.23t-test, 2 sided
p-value: =0.678t-test, 2 sided
p-value: =0.643t-test, 2 sided
p-value: =0.43t-test, 2 sided
p-value: =0.295t-test, 2 sided
p-value: =0.723t-test, 2 sided
p-value: =0.749t-test, 2 sided
p-value: =0.967Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.3 Percent Change from Baseline | Standard Deviation 2 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.8 Percent Change from Baseline | Standard Deviation 3 |
| BUN Clearance Elisio | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.3 Percent Change from Baseline | Standard Deviation 1.6 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.2 Percent Change from Baseline | Standard Deviation 1.9 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.1 Percent Change from Baseline | Standard Deviation 2.7 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.7 Percent Change from Baseline | Standard Deviation 2.1 |
| Phosphate Clearance Optiflux | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -0.9 Percent Change from Baseline | Standard Deviation 2.7 |
| Phosphate Clearance Revaclear | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.2 Percent Change from Baseline | Standard Deviation 2.8 |
| Phosphate Clearance Elisio | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.7 Percent Change from Baseline | Standard Deviation 2.3 |
| Beta 2 Microglobulin Revaclear | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 2.3 Percent Change from Baseline | Standard Deviation 5.2 |
| Beta 2 Microglobulin Optiflux | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 4.3 Percent Change from Baseline | Standard Deviation 4.3 |
| Beta 2 Microglobulin ELISIO | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 2.4 Percent Change from Baseline | Standard Deviation 4.6 |
p-value: =0.67t-test, 2 sided
p-value: =0.993t-test, 2 sided
p-value: =0.65t-test, 2 sided
p-value: =0.299t-test, 2 sided
p-value: =0.659t-test, 2 sided
p-value: =0.176t-test, 2 sided
p-value: =0.853t-test, 2 sided
p-value: =0.494t-test, 2 sided
p-value: =0.631t-test, 2 sided
p-value: =0.37t-test, 2 sided
p-value: =0.95t-test, 2 sided
p-value: =0.377t-test, 2 sided
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -6.2 Percent Change from Baseline | Standard Deviation 3.9 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.1 Percent Change from Baseline | Standard Deviation 4.1 |
| BUN Clearance Elisio | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.9 Percent Change from Baseline | Standard Deviation 5 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -5.0 Percent Change from Baseline | Standard Deviation 6.2 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.5 Percent Change from Baseline | Standard Deviation 4.5 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -9.1 Percent Change from Baseline | Standard Deviation 6.6 |
| Phosphate Clearance Optiflux | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -4.4 Percent Change from Baseline | Standard Deviation 7.8 |
| Phosphate Clearance Revaclear | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -4.8 Percent Change from Baseline | Standard Deviation 5.3 |
| Phosphate Clearance Elisio | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -7.3 Percent Change from Baseline | Standard Deviation 5.6 |
| Beta 2 Microglobulin Revaclear | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.0 Percent Change from Baseline | Standard Deviation 7.5 |
| Beta 2 Microglobulin Optiflux | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 0.7 Percent Change from Baseline | Standard Deviation 12.2 |
| Beta 2 Microglobulin ELISIO | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -1.2 Percent Change from Baseline | Standard Deviation 12.3 |
p-value: =0.114t-test, 2 sided
p-value: =0.292t-test, 2 sided
p-value: =0.714t-test, 2 sided
p-value: =0.176t-test, 2 sided
p-value: =0.19t-test, 2 sided
p-value: -0.009t-test, 2 sided
p-value: =0.911t-test, 2 sided
p-value: =0.388t-test, 2 sided
p-value: =0.337t-test, 2 sided
p-value: =0.575t-test, 2 sided
p-value: =0.88t-test, 2 sided
p-value: =0.731t-test, 2 sided
Primary
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.
Time frame: 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..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | 35.8 % Change from Baseline | Standard Deviation 99.5 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | -16.4 % Change from Baseline | Standard Deviation 44.3 |
| BUN Clearance Elisio | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | 52.7 % Change from Baseline | Standard Deviation 50.4 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | 895.3 % Change from Baseline | Standard Deviation 755 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | 474.7 % Change from Baseline | Standard Deviation 393.9 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | 545.2 % Change from Baseline | Standard Deviation 573.1 |
p-value: =0.204Wilcoxon (Mann-Whitney)
p-value: =0.234Wilcoxon (Mann-Whitney)
p-value: =0.015t-test, 2 sided
p-value: =0.413Wilcoxon (Mann-Whitney)
p-value: =0.314t-test, 2 sided
p-value: =0.769t-test, 2 sided
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BUN Clearance Optiflux | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -8.1 Percent Change from Baseline | Standard Deviation 8 |
| BUN Clearance Revaclear | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -5.8 Percent Change from Baseline | Standard Deviation 7.4 |
| BUN Clearance Elisio | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -10.1 Percent Change from Baseline | Standard Deviation 7.5 |
| Creatinine Clearance Optiflux | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -5.5 Percent Change from Baseline | Standard Deviation 6.5 |
| Creatinine Clearance Revaclear | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -0.8 Percent Change from Baseline | Standard Deviation 6.2 |
| Creatinine Clearance ELISIO | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.9 Percent Change from Baseline | Standard Deviation 8.2 |
| Phosphate Clearance Optiflux | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.9 Percent Change from Baseline | Standard Deviation 6.2 |
| Phosphate Clearance Revaclear | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -2.4 Percent Change from Baseline | Standard Deviation 5.1 |
| Phosphate Clearance Elisio | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.8 Percent Change from Baseline | Standard Deviation 5.3 |
| Beta 2 Microglobulin Revaclear | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -3.2 Percent Change from Baseline | Standard Deviation 12.4 |
| Beta 2 Microglobulin Optiflux | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | 2.9 Percent Change from Baseline | Standard Deviation 9.5 |
| Beta 2 Microglobulin ELISIO | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | -0.06 Percent Change from Baseline | Standard Deviation 6.4 |
p-value: =0.534t-test, 2 sided
p-value: =0.578t-test, 2 sided
p-value: =0.225t-test, 2 sided
p-value: =0.125t-test, 2 sided
p-value: =0.466t-test, 2 sided
p-value: =0.534t-test, 2 sided
p-value: =0.584t-test, 2 sided
p-value: =0.981t-test, 2 sided
p-value: =0.568t-test, 2 sided
p-value: =0.24t-test, 2 sided
p-value: =0.724Wilcoxon (Mann-Whitney)
p-value: =0.445t-test, 2 sided