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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Gambro Renal Products, Inc. | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The purposes of this study are to determine if the performance of a dialyzer depends on how tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane packing density) and if that dependence is a function of the dialysate flow rate. The study will examine how efficiently three different sized molecules pass through a dialyzer membrane at different dialysate flow rates in dialyzers with different membrane packing densities. Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be measured during clinical hemodialysis using four different dialyzers, each used at three different dialysate flow rates. The data derived from these measurements may provide insight into the importance of membrane packing density as a design parameter for hemodialyzers and if changing the membrane packing density might provide equivalent performance at a lower dialysate flow rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-C4 Big | Other | 3 consecutive treatments with the HD-C4 Big dialyzer. |
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| HD-C4 Small | Other | 3 consecutive treatments with the HD-C4 Small dialyzer. |
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| F160NR | Other | 3 consecutive treatments with the F160NR dialyzer. |
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| F200NR | Other | 3 consecutive treatments with the F200NR dialyzer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyflux HD-C4 Big | Device | Three consecutive treatments with the HD-C4 Big. During the third treatment, dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. | KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size. | During the third treatment with each dialyzer (one time during each trial period week) |
| Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | During the third treatment with each dialyzer (one time during each trial period week) | |
| Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities. | During the third treatment with each dialyzer (one time during each trial period week) | |
| Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | During the third treatment with each dialyzer (one time during each trial period week) | |
| Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities. | During the third treatment with each dialyzer (one time during each trial period week) | |
| Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | During the third treatment with each dialyzer (one time during each trial period week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Ward, Ph.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville, Kidney Disease Program | Louisville | Kentucky | 40202-1718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9186896 | Background | Leypoldt JK, Cheung AK, Agodoa LY, Daugirdas JT, Greene T, Keshaviah PR. Hemodialyzer mass transfer-area coefficients for urea increase at high dialysate flow rates. The Hemodialysis (HEMO) Study. Kidney Int. 1997 Jun;51(6):2013-7. doi: 10.1038/ki.1997.274. | |
| 11157372 | Background | Ouseph R, Ward RA. Increasing dialysate flow rate increases dialyzer urea mass transfer-area coefficients during clinical use. Am J Kidney Dis. 2001 Feb;37(2):316-20. doi: 10.1053/ajkd.2001.21296. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HD-C4 Big First | Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). |
| FG001 | HD-C4 Small First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 1 |
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| HD-C4 Small | Device | Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min. |
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| Optiflux 160NR | Device | Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min. |
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| Optiflux 200NR | Device | Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min. |
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| 5960730 | Background | Michaels AS. Operating parameters and performance criteria for hemodialyzers and other membrane-separation devices. Trans Am Soc Artif Intern Organs. 1966;12:387-92. No abstract available. |
| Background | Ward RA, Ouseph R: Comparative evaluation of small and large molecule removal during hemodialysis with Polyflux-S and Fresenius polysulfone membranes. Report to Gambro Renal Products, February 6, 2003. |
| Background | Ward RA, Ouseph R: A comparison of urea, phosphorus and b2-microglobulin removal during hemodialysis with dialyzers containing Polyflux H and Fresenius Optiflux membranes. Report to Gambro Renal Products, August 29, 2005. |
| 12558312 | Background | Leypoldt JK, Cheung AK, Chirananthavat T, Gilson JF, Kamerath CD, Deeter RB. Hollow fiber shape alters solute clearances in high flux hemodialyzers. ASAIO J. 2003 Jan-Feb;49(1):81-7. doi: 10.1097/00002480-200301000-00013. |
| Background | Ward RA, Ouseph R: Modification of membrane characteristics allows a reduction in dialyzer membrane area without loss of performance. J Am Soc Nephrol 18:453A, 2007. |
| Background | Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758 |
| 20543211 | Result | Bhimani JP, Ouseph R, Ward RA. Effect of increasing dialysate flow rate on diffusive mass transfer of urea, phosphate and beta2-microglobulin during clinical haemodialysis. Nephrol Dial Transplant. 2010 Dec;25(12):3990-5. doi: 10.1093/ndt/gfq326. Epub 2010 Jun 13. |
Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). |
| FG002 | Optiflux F160NR First | Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). |
| FG003 | Optiflux F200NR First | Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. | KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size. | Posted | Mean | Standard Error | KoA for urea (mL/min) | During the third treatment with each dialyzer (one time during each trial period week) |
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| Primary | Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | Posted | Mean | Standard Error | Whole blood urea clearance (mL/min) | During the third treatment with each dialyzer (one time during each trial period week) |
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| Primary | Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities. | Posted | Mean | Standard Error | KoA for Phosphorus (mL/min) | During the third treatment with each dialyzer (one time during each trial period week) |
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| Primary | Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | Posted | Mean | Standard Error | whole blood phosphorus clearance mL/min | During the third treatment with each dialyzer (one time during each trial period week) |
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| Primary | Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities. | Posted | Mean | Standard Error | KoA for b2-microglobulin (mL/min) | During the third treatment with each dialyzer (one time during each trial period week) |
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| Primary | Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities. | Posted | Mean | Standard Error | whole blood clearance B2-microglobulin | During the third treatment with each dialyzer (one time during each trial period week) |
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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 Big | 3 consecutive treatments with the HD-C4 Big dialyzer. | 0 | 12 | 0 | 12 | ||
| EG001 | HD-C4 Small | 3 consecutive treatments with the HD-C4 Small dialyzer. | 0 | 12 | 0 | 12 | ||
| EG002 | F160NR | 3 consecutive treatments with the F160NR dialyzer. | 0 | 12 | 0 | 12 | ||
| EG003 | F200NR | 3 consecutive treatments with the F200NR dialyzer. | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Vantive | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| 500 mL/min Dialysate Flow Rate |
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| 800 mL/min Dialysate Flow Rate |
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