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

Completed

Conditions studied: Kidney Failure, Chronic, End Stage Renal Disease, Requiring Dialysis

In brief

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.

Key facts

Study ID

NCT00288613

Run by

NxStage Medical

People needed

501

Starts

2006-01-01

Expected to finish

2013-11-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fort Smith Regional Dialysis Center — Fort Smith, Arkansas, United States
• Arkansas Nephrology Research Associates — Hot Springs, Arkansas, United States
• Renal Advantage (RAI) — Garden Grove, California, United States
• Satellite Healthcare/Wellbound — Mountain View, California, United States
• Renal Advantage (RAI) — Oakland, California, United States
• Kidney Center, Inc. — Simi Valley, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Metabolism Associates - New Haven CAPD — New Haven, Connecticut, United States
• RAI Palm Harbor, Outcomes Research Int'l — Hudson, Florida, United States
• Emory, Renal Care Partners of Dunwoody — Sandy Springs, Georgia, United States
• Circle Medical Management — Chicago, Illinois, United States
• Affiliated Home Dialysis — Glen Ellyn, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Nephrology, Inc. — Mishawaka, Indiana, United States
• Kansas Dialysis Services — Topeka, Kansas, United States
• University of Louisvile KDP — Louisville, Kentucky, United States
• Dialysis at Home, Inc — Brighton, Massachusetts, United States
• Great Lakes Renal Network — Alma, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Munson Dialysis Center — Traverse City, Michigan, United States
• Renal Advantage (RAI) — Wyoming, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NRA Home — Frontenac, Missouri, United States
• Washington University/Barnes Jewish Dialysis Center — St Louis, Missouri, United States
• Dialysis Center of Lincoln — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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