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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Failure, Chronic, End-Stage Renal Disease

Intervention / Treatment
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* Device: NxStage System One


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home Short Daily Hemodialysis<br>Intervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. | Device: NxStage System One<br>* Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One<br>|
| Experimental: Home Nocturnal Hemodialysis<br>Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. | Device: NxStage System One<br>* Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, End Stage Renal Disease, Daily Hemodialysis, Nocturnal Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease