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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
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
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
  Show All Outcome Measures

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  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:
Other Publications:

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