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

• 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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: Yes ]
  The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
  
  

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.