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FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

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ClinicalTrials.gov Identifier: NCT00288613
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : July 24, 2014
Information provided by (Responsible Party):
NxStage Medical

Brief Summary:
Purpose The purpose of this study is to compare the economical impact and clinical parameters of short daily hemodialysis using the NxStage® System One hemodialysis device with thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database.

Condition or disease
Kidney Failure, Chronic End Stage Renal Disease, Requiring Dialysis

Detailed Description:
In the 21st century, nephrologists in the United States face many challenges including a forecast of decline in physician manpower. Challenges that are specific to hemodialysis (HD) include reimbursement constraints, a growing shortage of nurses and major technological advances in dialysis equipment. There is a growing interest in alternative dialysis regimen and frequency, but a lack of patient incentive for self-care dialysis either in the center or in the home setting. The proposed phase 4 post-marketing study plans to explore whether daily HD is economically attractive compared with thrice weekly HD, while improving health-related quality of life and other dialysis adequacy measures. This project is unique as it provides a large prospective cohort of patients converted to daily HD, with a longitudinal follow up and an ability to compare to a matched cohort from the United States Renal Data Services. This study will help develop whether daily dialysis is economically attractive through the use of new technologies that reduce treatment costs and decrease hospitalization rates, with the long-term hope of increasing life expectancy. All patients will have the option to participate in the Quotidian Dialysis Registry, coordinated by the Lawson Health Research Institute (LHRI) in London, Ontario.

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Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
Study Start Date : January 2006
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Primary Outcome Measures :
  1. Hospitalizations [ Time Frame: duration of study participation ]
    To compare the all-cause hospitalizations reported in days per patient year on daily hemodialysis using NxStage System One hemodialysis device to thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with ESRD who are candidates for daily hemodialysis with the NxStage System One and have Medicare as the primary payor.

Inclusion Criteria:

  • Diagnosis of ESRD and require dialysis
  • Medicare as primary payor (NOTE: Does not include Medicare HMO as primary payer)
  • Candidate for daily hemodialysis (defined as 6 or more times per week)
  • Ability to understand and willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement

Exclusion Criteria:

  • Current use of the NxStage System One hemodialysis device
  • Previous enrollment in this study
  • Current enrollment in another investigational drug or device trial which might impact the outcome measures planned in this study
  • Likelihood of not surviving the training period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288613

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Sponsors and Collaborators
NxStage Medical
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Principal Investigator: Bertrand L. Jaber, MD, FASN Unaffilated
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00288613    
Other Study ID Numbers: CP0009
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by NxStage Medical:
Daily Hemodialysis
Kidney Failure
Kidney Disease
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic