NCT00667511|CompletedResultsDMC
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Sponsor study identifier
interventional
58
1 country
9
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2008
Actual (reported)April 28, 2008
Actual (reported)May 2014
Actual (reported)May 2014
Actual (reported)January 14, 2015
Actual (reported)Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
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).
Study Week 20
Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Study Week 20
Intervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Satellite Healthcare/Wellbound
San Jose, California, 95128, United States
Circle Medical Management
Chicago, Illinois, 60607, United States
Indiana University Dialysis Center
Indianapolis, Indiana, 46202, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
Barnes Jewish Dialysis Center
St Louis, Missouri, 63110, United States
Dialysis Center of Lincoln
Lincoln, Nebraska, 68512, United States
Rubin Dialysis
Saratoga Springs, New York, 12866, United States
Liu F, Abra G, Gupta N, Schiller B, Rivara MB. How I Treat Nocturnal Home Hemodialysis-An Underprescribed but Essential Home Dialysis Modality in the United States. Clin J Am Soc Nephrol. 2025 Oct 10;21(5):907-9. doi: 10.2215/CJN.0000000927. Online ahead of print. No abstract available.
Paul Kravitz
NxStage Medical
58 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
Contact the study team to confirm eligibility.
DaVita Grapevine at Home
Grapevine, Texas, 76051, United States
DaVita Bluemound Home Dialysis
Wauwatosa, Wisconsin, 53226, United States
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
January 14, 2015
Results First Posted
January 14, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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