Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis

This study has been completed.

Sponsor:

Collaborator:

University of Louisville

Information provided by:

Gambro Renal Products, Inc.

ClinicalTrials.gov Identifier:

NCT00636077

First received: February 20, 2008

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Results First Received: March 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Kidney Disease Chronic Renal Disease
Interventions:	Device: Polyflux HD-C4 Big Device: HD-C4 Small Device: Optiflux 160NR Device: Optiflux 200NR

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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).
HD-C4 Small First	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).
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).
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).

Participant Flow for 4 periods

Period 1: Week 1

	HD-C4 Big First	HD-C4 Small First	Optiflux F160NR First	Optiflux F200NR First
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 2: Week 2

	HD-C4 Big First	HD-C4 Small First	Optiflux F160NR First	Optiflux F200NR First
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 3: Week 3

	HD-C4 Big First	HD-C4 Small First	Optiflux F160NR First	Optiflux F200NR First
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 4: Week 4

	HD-C4 Big First	HD-C4 Small First	Optiflux F160NR First	Optiflux F200NR First
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
All Study Participants	No text entered.

Baseline Measures

	All Study Participants
Number of Participants [units: participants]	12
Age [units: Years] Mean ( Full Range )	60 ( 32 to 83 )
Gender [units: participants]
Female	9
Male	3

Outcome Measures

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1. Primary:

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) ]

Show Outcome Measure 1

2. Primary:

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) ]

Show Outcome Measure 2

3. Primary:

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) ]

Show Outcome Measure 3

4. Primary:

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) ]

Show Outcome Measure 4

5. Primary:

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) ]

Show Outcome Measure 5

6. Primary:

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) ]

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Richard A Ward, Ph.D.
Organization: Kidney Disease Program, University of Louisville
phone: 502-852-5757
e-mail: richard.ward@louisville.edu

Publications of Results:

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.

Other 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.

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.

Michaels AS. Operating parameters and performance criteria for hemodialyzers and other membrane-separation devices. Trans Am Soc Artif Intern Organs. 1966;12:387-92.

Leypoldt JK, Cheung AK, Carroll CE, Stannard DC, Pereira BJ, Agodoa LY, Port FK. Effect of dialysis membranes and middle molecule removal on chronic hemodialysis patient survival. Am J Kidney Dis. 1999 Feb;33(2):349-55.

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.

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.

Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758

Responsible Party:	Richard A. Ward, Ph.D./Professor of Medicine, University of Louisville
ClinicalTrials.gov Identifier:	NCT00636077 History of Changes
Other Study ID Numbers:	Gambro 1461
Study First Received:	February 20, 2008
Results First Received:	March 7, 2011
Last Updated:	June 6, 2011
Health Authority:	United States: Institutional Review Board

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