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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667511
• Other study ID #: CP0010
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: January 12, 2015
• Start date: April 2008
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: NxStage Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Circle Medical Management	Chicago	Illinois
United States	DaVita Grapevine at Home	Grapevine	Texas
United States	Indiana University Dialysis Center	Indianapolis	Indiana
United States	Dialysis Center of Lincoln	Lincoln	Nebraska
United States	Satellite Healthcare/Wellbound	San Jose	California
United States	Rubin Dialysis	Saratoga Springs	New York
United States	Barnes Jewish Dialysis Center	St. Louis	Missouri
United States	DaVita Bluemound Home Dialysis	Wauwatosa	Wisconsin
United States	Kansas Nephrology Research Institute, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
NxStage Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes