Chronic Kidney DiseaseNCT00636077
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
A study testing Polyflux HD-C4 Big, HD-C4 Small and Optiflux 160NR in people with Chronic Kidney Disease and Chronic Renal Disease, run by Vantive Health LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, Chronic Renal Disease
- What is being tested?
- Polyflux HD-C4 Big, HD-C4 Small and Optiflux 160NR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable hemodialysis patients dialyzing through a native fistula or Gore-Tex graft. The access must be capable of delivering a stable blood flow of 400 ml/min.
- Age older than 18 years.
- Fluid removal requirement less than 3 liters per treatment.
Who cannot join
- Noncompliance with dialysis regimen.
- Hematocrit less than 28%.
- Active infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville, Kidney Disease Program
Louisville, Kentucky, 40202-1718
About this study
Official title: Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities
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.
- Conditions
- Chronic Kidney Disease, Chronic Renal Disease
- Being tested
- Polyflux HD-C4 Big, HD-C4 Small, Optiflux 160NR, Optiflux 200NR
- Keywords
- Hemodialysis, Dialysis, Renal
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyflux HD-C4 BigDevice
Also called Gambro Polyflux HD-C4 Big dialyzer, Gambro Revaclear MAX
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.
HD-C4 SmallDevice
Also called Gambro Polyflux HD-C4 Small dialyzer, Gambro Revaclear dialyzer
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.
Optiflux 160NRDevice
Also called Fresenius Optiflux 160NR
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.
Optiflux 200NRDevice
Also called Fresenius Optiflux 200NR
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.
| Study group | Role | What they receive |
|---|---|---|
| HD-C4 Big | Other | 3 consecutive treatments with the HD-C4 Big dialyzer. Receives: Device: Polyflux HD-C4 Big |
| HD-C4 Small | Other | 3 consecutive treatments with the HD-C4 Small dialyzer. Receives: Device: HD-C4 Small |
| F160NR | Other | 3 consecutive treatments with the F160NR dialyzer. Receives: Device: Optiflux 160NR |
| F200NR | Other | 3 consecutive treatments with the F200NR dialyzer. Receives: Device: Optiflux 200NR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the third treatment with each dialyzer (one time during each trial period week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Louisville, Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Richard Ward, Ph.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636077
- Sponsor's protocol ID
- Gambro 1461
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2008
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 9186896Ouseph 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.
PubMed 11157372Michaels 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.
PubMed 5960730Ward 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.
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.
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.
PubMed 12558312Ward 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.
Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758
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.
PubMed 20543211
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities
- ClinicalTrials.gov ID
- NCT00636077
- Acronym / sponsor ID
- Gambro 1461
- Conditions
- Chronic Kidney Disease, Chronic Renal Disease
- Keywords
- Hemodialysis, Dialysis, Renal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Louisville, Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 1 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HD-C4 Big | Other | Device: Polyflux HD-C4 Big3 consecutive treatments with the HD-C4 Big dialyzer. |
| HD-C4 Small | Other | Device: HD-C4 Small3 consecutive treatments with the HD-C4 Small dialyzer. |
| F160NR | Other | Device: Optiflux 160NR3 consecutive treatments with the F160NR dialyzer. |
| F200NR | Other | Device: Optiflux 200NR3 consecutive treatments with the F200NR dialyzer. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable hemodialysis patients dialyzing through a native fistula or Gore-Tex graft. The access must be capable of delivering a stable blood flow of 400 ml/min.
- Age older than 18 years.
- Fluid removal requirement less than 3 liters per treatment.
Key exclusion criteria (3 listed)
- Noncompliance with dialysis regimen.
- Hematocrit less than 28%.
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyflux HD-C4 BigAlso: Gambro Polyflux HD-C4 Big dialyzer, Gambro Revaclear MAXThree 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. | Device | HD-C4 Big |
| HD-C4 SmallAlso: Gambro Polyflux HD-C4 Small dialyzer, Gambro Revaclear dialyzerThree 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. | Device | HD-C4 Small |
| Optiflux 160NRAlso: Fresenius Optiflux 160NRThree 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. | Device | F160NR |
| Optiflux 200NRAlso: Fresenius Optiflux 200NRThree 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. | Device | F200NR |
Primary outcome
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.
Time frame: During the third treatment with each dialyzer (one time during each trial period week)
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.
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the third treatment with each dialyzer (one time during each trial period week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9186896Leypoldt 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.
- Background: PubMed 11157372Ouseph 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.
- Background: PubMed 5960730Michaels 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.
- BackgroundWard 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.
- BackgroundWard 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.
- Background: PubMed 12558312Leypoldt 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.
- BackgroundWard 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.
- BackgroundChen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758
- Results publication: PubMed 20543211Bhimani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Ward, Ph.D. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyflux HD-C4 Big, HD-C4 Small and Optiflux 160NR in people with Chronic Kidney Disease and Chronic Renal Disease, run by Vantive Health LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. (time frame: During the third treatment with each dialyzer (one time during each trial period week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636077, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.