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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Kidney Failure, Chronic; End-Stage Renal Disease	Device: NxStage System One	Not Applicable

Detailed Description:

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	Device: NxStage System One; Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the 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.	Device: NxStage System One; Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One

Outcome Measures

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Primary Outcome Measures :

1. 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).
2. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

NxStage Medical

Investigators

Study Director:	Paul Kravitz	NxStage Medical

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	NxStage Medical
ClinicalTrials.gov Identifier:	NCT00667511 History of Changes
Other Study ID Numbers:	CP0010
First Posted:	April 28, 2008
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