Clincal trials: Comparison of Nocturnal Hemodialysis & Short Daily Hemodialysis

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

This study is currently recruiting participants.
Verified by NxStage Medical, June 2008

Sponsored by:    NxStage Medical
Information provided by:    NxStage Medical
ClinicalTrials.gov Identifier:    NCT00667511
Purpose

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
Kidney Failure, Chronic
End Stage Renal Disease, Requiring Dialysis

MedlinePlus related topics:     Dialysis Kidney Failure

U.S. FDA Resources

Study Type:     Observational
Study Design:     Case-Only, Prospective
Official Title:     Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™

Further study details as provided by NxStage Medical:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:     30
Study Start Date:     April 2008
Estimated Study Completion Date:     December 2009

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. USRDS 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
Ages Eligible for Study:     18 Years and older
Genders Eligible for Study:     Both
Accepts Healthy Volunteers:     No
Sampling Method:     Non-Probability Sample

Study Population

Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.

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:
o they are currently enrolled in another drug or device study which could impact the successful completion of this study
o they are currently on NHD, or less than 3 months since discontinuing NHD
o if they were previously enrolled in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667511

Locations
United States, California
   Satellite Healthcare/Wellbound        Recruiting
     Mountain View, California, United States, 94041
     Contact: Jugjeet Atwal 408-309-5847
     Principal Investigator: Brigitte Schiller-Moran, MD
United States, Missouri
   Barnes Jewish Dialysis Center        Recruiting
     St. Louis, Missouri, United States, 63110
     Contact: Janet Riley 314-286-0804
     Principal Investigator: Brent Miller, MD
United States, Nebraska
   Dialysis Center of Lincoln        Recruiting
     Lincoln, Nebraska, United States, 68512
     Contact: Michelle Carver 402-742-8500
     Principal Investigator: Leslie Spry, MD
     Sub-Investigator: Timothy Govaerts, MD
United States, New York
   Rubin Dialysis        Recruiting
     Saratoga Springs, New York, United States, 12866
     Contact: Shari Meola 518-271-0702
     Principal Investigator: Christopher Hoy, MD
     Principal Investigator: Rachid Daoui, MD
United States, Wisconsin
   Commonwealth Dialysis        Recruiting
     Greenfield, Wisconsin, United States, 53220
     Contact: Gail Scott 414-281-6806 gscott@thekidneyinstitute.com
     Principal Investigator: William Elliott, MD

Sponsors and Collaborators
NxStage Medical

Investigators
Study Director:     Paul Clark     NxStage Medical
More Information

Responsible Party:     NxStage Medical, Inc. ( Paul Clark, Director of Clinical and Regulatory Affairs )
Study ID Numbers:     CP0010
First Received:     April 24, 2008
Last Updated:     June 23, 2008
ClinicalTrials.gov Identifier:     NCT00667511
Health Authority:     United States: Food and Drug Administration

Keywords provided by NxStage Medical:
ESRD
End Stage Renal Disease
Daily Hemodialysis
Nocturnal Hemodialysis

Hemodialysis
Kidney Failure
Kidney Disease

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 23, 2008
http://clinicaltrials.gov/ct2/show/NCT00667511