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Sponsored by: |
NxStage Medical |
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Information provided by: | NxStage Medical |
ClinicalTrials.gov Identifier: | NCT00667511 |
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 |
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Kidney Failure, Chronic End Stage Renal Disease, Requiring Dialysis |
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™ |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.
Inclusion Criteria:
Exclusion Criteria:
Patients are not eligible if:
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, Illinois | |
Circle Medical Management | Recruiting |
Chicago, Illinois, United States, 60607 | |
Contact: Janice Ferrell 312-829-1424 | |
Principal Investigator: William Whittier, 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 |
Study Director: | Paul Clark | NxStage Medical |
Responsible Party: | NxStage Medical, Inc. ( Paul Clark, Director of Clinical and Regulatory Affairs ) |
Study ID Numbers: | CP0010 |
Study First Received: | April 24, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00667511 |
Health Authority: | United States: Food and Drug Administration |
ESRD End Stage Renal Disease Daily Hemodialysis Nocturnal Hemodialysis |
Hemodialysis Kidney Failure Kidney Disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |