Status:
COMPLETED
FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
Lead Sponsor:
NxStage Medical
Conditions:
Kidney Failure, Chronic
End Stage Renal Disease, Requiring Dialysis
Eligibility:
All Genders
18+ years
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 conventio...
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 reimbursem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00288613
Start Date
January 1 2006
End Date
November 1 2013
Last Update
July 24 2014
Active Locations (41)
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1
Fort Smith Regional Dialysis Center
Fort Smith, Arkansas, United States, 72901
2
Arkansas Nephrology Research Associates
Hot Springs, Arkansas, United States, 71901
3
Renal Advantage (RAI)
Garden Grove, California, United States, 92843
4
Satellite Healthcare/Wellbound
Mountain View, California, United States, 94041