Chronic Kidney Disease
Conditions
Keywords
Hemodialysis, Dialysis, Renal, Dialysis, Extracorporeal, Extracorporeal Dialysis
Brief summary
The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device. The objectives of this study are: 1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and, 2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.
Interventions
DEVICEPolyflux 210H dialyzer
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
DEVICEPolyflux HD-C4
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Sponsors
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years of age or older * Stable hemodialysis prescription using Polyflux 210H or Polyflux 21R for at least 2 months prior to study enrollment * Dialyzing through a native fistula or Gore-Tex graft. * Blood access must be able to provide a blood flow rate of 400 ml/min.
Exclusion criteria
* Non-compliance with dialysis * Hematocrit less than 28% * Active Infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Urea Removal Under Conditions of Routine Hemodialysis. | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments | Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V. |
| A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments | Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments | Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor / |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 50.2 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
Primary
A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.
Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.
Time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HD-C4 | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | Urea Pre- to post-dialysis reduction (%) | 74 Percentage of reduction | Standard Deviation 6 |
| HD-C4 | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | Phosphorus Pre- to post-dialysis reduction (%) | 61 Percentage of reduction | Standard Deviation 9 |
| HD-C4 | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | b2-microglobulin Pre- to post-dialysis reduct (%) | 52 Percentage of reduction | Standard Deviation 12 |
| 210H | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | Urea Pre- to post-dialysis reduction (%) | 74 Percentage of reduction | Standard Deviation 5 |
| 210H | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | Phosphorus Pre- to post-dialysis reduction (%) | 60 Percentage of reduction | Standard Deviation 17 |
| 210H | A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. | b2-microglobulin Pre- to post-dialysis reduct (%) | 58 Percentage of reduction | Standard Deviation 8 |
Primary
Comparison of Urea Removal Under Conditions of Routine Hemodialysis.
Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.
Time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HD-C4 | Comparison of Urea Removal Under Conditions of Routine Hemodialysis. | Single-pool Kt/V Urea | 1.64 ratio | Standard Deviation 0.26 |
| HD-C4 | Comparison of Urea Removal Under Conditions of Routine Hemodialysis. | Equilibrated Kt/V | 1.42 ratio | Standard Deviation 0.22 |
| 210H | Comparison of Urea Removal Under Conditions of Routine Hemodialysis. | Single-pool Kt/V Urea | 1.61 ratio | Standard Deviation 0.24 |
| 210H | Comparison of Urea Removal Under Conditions of Routine Hemodialysis. | Equilibrated Kt/V | 1.40 ratio | Standard Deviation 0.22 |
Secondary
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H
Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /
Time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
Population: Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HD-C4 | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Priming of dialysate compartment | 1.36 Units on a Scale 1 = Best | Standard Deviation 0.49 |
| HD-C4 | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of arterial header | 1.61 Units on a Scale 1 = Best | Standard Deviation 0.55 |
| HD-C4 | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of fibers | 1.42 Units on a Scale 1 = Best | Standard Deviation 0.55 |
| HD-C4 | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of venous header | 1.57 Units on a Scale 1 = Best | Standard Deviation 0.74 |
| HD-C4 | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Priming of blood compartment | 1.19 Units on a Scale 1 = Best | Standard Deviation 0.4 |
| 210H | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of venous header | 1.77 Units on a Scale 1 = Best | Standard Deviation 0.55 |
| 210H | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Priming of blood compartment | 1.47 Units on a Scale 1 = Best | Standard Deviation 0.51 |
| 210H | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Priming of dialysate compartment | 1.51 Units on a Scale 1 = Best | Standard Deviation 0.51 |
| 210H | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of fibers | 1.78 Units on a Scale 1 = Best | Standard Deviation 0.64 |
| 210H | Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H | Appearance of arterial header | 1.72 Units on a Scale 1 = Best | Standard Deviation 0.51 |