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Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate

This study has been completed.
Sponsor:
Collaborators:
University of Louisville
Vanderbilt University
University of California, Davis
Information provided by:
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00962000
First received: August 18, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Chronic Renal Disease
Intervention: Other: Dialysis Flow Rate

  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
600 mL/Min First Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
800 mL/Min First Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.

Participant Flow for 4 periods

 Period 1:   Period 1 - 1 Week
    600 mL/Min First     800 mL/Min First  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 2:   Period 2 - 1 Week
    600 mL/Min First     800 mL/Min First  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 3:   Period 3 - 1 Week
    600 mL/Min First     800 mL/Min First  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 4:   Period 4 - 1 Week
    600 mL/Min First     800 mL/Min First  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
All Study Participants All subjects who participated in the study.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
 		  42  
Age  
[units: years]
Mean ( Full Range ) 		 
>=18 years     50  
  ( 19 to 85 )  
Gender  
[units: participants]
 		 
Female     16  
Male     26  
Pre-dialysis Weight  
[units: kg]
Mean ( Full Range ) 		 
United States     84  
  ( 48 to 147 )  



  Outcome Measures
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1.  Primary:   Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.   [ Time Frame: 4 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.   [ Time Frame: 4 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Kt/V Determined From Measurements of Ionic Dialysance   [ Time Frame: 4 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications:


Responsible Party: Richard A. Ward, Ph.D./Professor of Medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT00962000     History of Changes
Other Study ID Numbers: Gambro PI 2009
Study First Received: August 18, 2009
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board