ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

April 24, 2008
April 28, 2008
December 22, 2014
January 14, 2015
January 14, 2015
April 2008
May 2014   (Final data collection date for primary outcome measure)
  • 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 ]
    The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).
  • 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 ]
    The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Not Provided
Complete list of historical versions of study NCT00667511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.

End Stage Renal Disease (ESRD) continues to be a devastating clinical condition. The number of patients in 2004 affected by ESRD in the United States rose to 472,000. More than 104,000 new patients began therapy for ESRD in 2004 (1.5% greater than in 2003), while the prevalent dialysis population reached nearly 336,000 (3.4% higher). Total Medicare costs for ESRD in 2004 rose to $20.1 billion while non-Medicare costs rose to $12.4 Billion(1).

Treatment options for ESRD patients are currently limited to either transplantation or dialysis. As daily hemodialysis (DHD) continues to gain widespread acceptance in the dialysis community, there is also renewed interest in nocturnal hemodialysis (NHD) therapy.

NHD has the potential to provide certain advantages over both DHD and conventional thrice-weekly in-center HD. NHD typically consists of 6 - 10 hour treatments while the patient sleeps, providing more gentle fluid removal, more time for equilibration, improved hemodynamic stability and superior clearance of larger solutes(2).

The proposed study plans to explore whether or not NHD is equivalent to DHD on a per treatment basis, using the NxStage System One in the home setting.

  1. United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006
  2. Lacson E, Diaz-Buxo J: Daily and Nocturnal Hemodialysis: How do they stack up? American Journal Kidney Disease, Vol 38(2) Aug 2001: 225-239.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Failure, Chronic
  • End-Stage Renal Disease
Device: NxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
  • Active Comparator: Home Short Daily Hemodialysis
    Intervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
    Intervention: Device: NxStage System One
  • Experimental: Home Nocturnal Hemodialysis
    Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
    Intervention: Device: NxStage System One
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
30
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.

Exclusion Criteria:

  • Patients are not eligible if:

    • they are currently enrolled in another drug or device study which could impact the successful completion of this study
    • they are currently on NHD, or less than 3 months since discontinuing NHD
    • if they were previously enrolled in this study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00667511
CP0010
Yes
Not Provided
Not Provided
NxStage Medical
NxStage Medical
Not Provided
Study Director: Paul Kravitz NxStage Medical
NxStage Medical
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP