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

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ClinicalTrials.gov Identifier: NCT00636077
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : July 1, 2011
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
University of Louisville
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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.
No text entered.

Reporting Groups
  Description
All Study Participants No text entered.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 		 12 
Age 
[Units: Years]
Mean (Full Range) 		 60 
 (32 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      9  75.0% 
Male      3  25.0% 


  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) ]
  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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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:
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.
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.
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: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00636077     History of Changes
Other Study ID Numbers: Gambro 1461
First Submitted: February 20, 2008
First Posted: March 14, 2008
Results First Submitted: March 7, 2011
Results First Posted: July 1, 2011
Last Update Posted: May 10, 2017