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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Failure, Chronic End-Stage Renal Disease | Device: NxStage System One | Not Applicable |
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.
- United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™ |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Device: NxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
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Experimental: Home Nocturnal Hemodialysis
Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
|
Device: NxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.
Exclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667511
United States, California | |
Satellite Healthcare/Wellbound | |
San Jose, California, United States, 95128 | |
United States, Illinois | |
Circle Medical Management | |
Chicago, Illinois, United States, 60607 | |
United States, Indiana | |
Indiana University Dialysis Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kansas | |
Kansas Nephrology Research Institute, LLC | |
Wichita, Kansas, United States, 67214 | |
United States, Missouri | |
Barnes Jewish Dialysis Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Dialysis Center of Lincoln | |
Lincoln, Nebraska, United States, 68512 | |
United States, New York | |
Rubin Dialysis | |
Saratoga Springs, New York, United States, 12866 | |
United States, Texas | |
DaVita Grapevine at Home | |
Grapevine, Texas, United States, 76051 | |
United States, Wisconsin | |
DaVita Bluemound Home Dialysis | |
Wauwatosa, Wisconsin, United States, 53226 |
Study Director: | Paul Kravitz | NxStage Medical |
Responsible Party: | NxStage Medical |
ClinicalTrials.gov Identifier: | NCT00667511 History of Changes |
Other Study ID Numbers: |
CP0010 |
First Posted: | April 28, 2008 Key Record Dates |
Results First Posted: | January 14, 2015 |
Last Update Posted: | January 14, 2015 |
Last Verified: | January 2015 |
Keywords provided by NxStage Medical:
ESRD End Stage Renal Disease Daily Hemodialysis Nocturnal Hemodialysis |
Hemodialysis Kidney Failure Kidney Disease |
Additional relevant MeSH terms:
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |