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

Completed

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

• Registration Number: NCT00288613
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalizations	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

Trial Locations

Locations (37)

Fort Smith Regional Dialysis Center; 🇺🇸 Fort Smith, Arkansas, United States

Arkansas Nephrology Research Associates; 🇺🇸 Hot Springs, Arkansas, United States

Renal Advantage (RAI); 🇺🇸 Hampton, Virginia, United States

Satellite Healthcare/Wellbound; 🇺🇸 Mountain View, 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

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