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| Name | Class |
|---|---|
| Gambro Renal Products, Inc. | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-C4 First, then 210H | Other | Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects will be switched to the Polyflux 210H dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments. |
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| 210H First, then HD-C4 | Other | Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects will be switched to the Polyflux HD-C4 dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyflux 210H dialyzer | Device | Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments |
| 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. | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments |
| Measure | Description | Time Frame |
|---|---|---|
| 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 / |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Alcorn Jr., PharmD | Davita Clinical Research Facility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research Facility | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8305648 | Background | Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13. doi: 10.1681/ASN.V451205. | |
| 8573901 | Background | Daugirdas JT, Schneditz D. Overestimation of hemodialysis dose depends on dialysis efficiency by regional blood flow but not by conventional two pool urea kinetic analysis. ASAIO J. 1995 Jul-Sep;41(3):M719-24. doi: 10.1097/00002480-199507000-00107. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HD-C4 First (Period 1), Then 210H (Period 2) | Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments. |
| FG001 | 210H First (Period 1), Then HD-C4 (Period 2) | Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - 1 Week |
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| Period 2 - 1 Week |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ratio | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments |
|
1 year, 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HD-C4 First (Period 1), Then 210H (Period 2) | Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Vantive | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Polyflux HD-C4 | Device | Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode. |
|
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| 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| 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 / | Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H. | Posted | Mean | Standard Deviation | Units on a Scale 1 = Best | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments | dialyzers | dialyzers |
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| 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. | Posted | Mean | Standard Deviation | Percentage of reduction | 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments |
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| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 210H First (Period 1), Then HD-C4 (Period 2) | Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments. | 0 | 5 | 0 | 5 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Appearance of fibers |
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| Appearance of arterial header |
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| Appearance of venous header |
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| b2-microglobulin Pre- to post-dialysis reduct (%) |
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