NCT00636077

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 1, 2011

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

February 20, 2008

Results QC Date

March 7, 2011

Last Update Submit

July 3, 2025

Conditions

Chronic Kidney DiseaseChronic Renal Disease

Keywords

HemodialysisDialysis, Renal

Outcome Measures

Primary Outcomes (6)

  • 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)

Study Arms (4)

HD-C4 Big

OTHER

3 consecutive treatments with the HD-C4 Big dialyzer.

Device: Polyflux HD-C4 Big

HD-C4 Small

OTHER

3 consecutive treatments with the HD-C4 Small dialyzer.

Device: HD-C4 Small

F160NR

OTHER

3 consecutive treatments with the F160NR dialyzer.

Device: Optiflux 160NR

F200NR

OTHER

3 consecutive treatments with the F200NR dialyzer.

Device: Optiflux 200NR

Interventions

Polyflux HD-C4 BigDEVICE

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.

Also known as: Gambro Polyflux HD-C4 Big dialyzer, Gambro Revaclear MAX
HD-C4 Big
HD-C4 SmallDEVICE

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.

Also known as: Gambro Polyflux HD-C4 Small dialyzer, Gambro Revaclear dialyzer
HD-C4 Small
Optiflux 160NRDEVICE

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.

Also known as: Fresenius Optiflux 160NR
F160NR
Optiflux 200NRDEVICE

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.

Also known as: Fresenius Optiflux 200NR
F200NR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Noncompliance with dialysis regimen.
  • Hematocrit less than 28%.
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville, Kidney Disease Program

Louisville, Kentucky, 40202-1718, United States

Location

Related Publications (9)

  • 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.

    PMID: 9186896BACKGROUND

  • 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.

    PMID: 11157372BACKGROUND

  • 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.

    PMID: 5960730BACKGROUND

  • 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.

    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.

    PMID: 12558312BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 20543211RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Global CORP Clinical Trials Disclosure
Organization
Vantive
Global.CORP.ClinicalTrialsDisclosure@vantive.com
+1 2249484283

Study Officials

  • Richard Ward, Ph.D.

    University of Louisville

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2008

First Posted

March 14, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 14, 2025

Results First Posted

July 1, 2011

Record last verified: 2025-07

Locations

US(1)