Clinical trial NCT00667511: Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Official title: Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
End-Stage Renal Disease
Keywords: ESRD
End Stage Renal Disease
Daily Hemodialysis
Nocturnal Hemodialysis
Hemodialysis
Kidney Failure
Kidney Disease
Lead sponsor: NxStage Medical
Sponsor class: OTHER
First posted: 2008-04-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
timeFrame: Study Week 20
measure: Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
timeFrame: Study Week 20
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Satellite Healthcare/Wellbound
state: California
city: Chicago
country: United States
facility: Circle Medical Management
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Dialysis Center
state: Indiana
city: Wichita
country: United States
facility: Kansas Nephrology Research Institute, LLC
state: Kansas
city: St. Louis
country: United States
facility: Barnes Jewish Dialysis Center
state: Missouri
city: Lincoln
country: United States
facility: Dialysis Center of Lincoln
state: Nebraska
city: Saratoga Springs
country: United States
facility: Rubin Dialysis
state: New York
city: Grapevine
country: United States
facility: DaVita Grapevine at Home
state: Texas
city: Wauwatosa
country: United States
facility: DaVita Bluemound Home Dialysis
state: Wisconsin
Study officials:
affiliation: NxStage Medical
name: Paul Kravitz
role: STUDY_DIRECTOR
References: