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Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™

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ClinicalTrials.gov Identifier: NCT00667511
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
NxStage Medical

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Kidney Failure, Chronic
End-Stage Renal Disease
Intervention: Device: NxStage System One

  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
Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis

Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.

Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.

In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out.


Participant Flow for 3 periods

Period 1:   Intervention 1: Home DHD
    Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
STARTED   58 
COMPLETED   51 
NOT COMPLETED   7 

Period 2:   Training/Transition Period
    Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
STARTED   51 
COMPLETED   43 
NOT COMPLETED   8 

Period 3:   Intervention 2: Home NHD
    Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
STARTED   43 
COMPLETED   39 
NOT COMPLETED   4 



  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.
58 patients were enrolled in the cross-over study. Patients were required to complete the home short daily hemodialysis phase before transitioning to the home nocturnal hemodialysis phase.

Reporting Groups
  Description
Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis

Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.

Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.


Baseline Measures
   Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis 
Overall Participants Analyzed 
[Units: Participants]
 58 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (13) 
Gender 
[Units: Participants]
 
Female   20 
Male   38 


  Outcome Measures

1.  Primary:   Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.   [ Time Frame: Study Week 20 ]

2.  Primary:   Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.   [ Time Frame: Study Week 20 ]


  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 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.


Results Point of Contact:  
Name/Title: Kristen Sheppard
Organization: NxStage Medical, Inc.
phone: 978-687-4700



Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00667511     History of Changes
Other Study ID Numbers: CP0010
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: December 22, 2014
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015