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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288613
• Other study ID #: CP0009
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2006
• Last updated: July 22, 2014
• Start date: January 2006
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: NxStage Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Disease, Requiring Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
United States	Great Lakes Renal Network	Alma	Michigan
United States	University of Colorado Hospital	Aurora	Colorado
United States	Dialysis at Home, Inc	Brighton	Massachusetts
United States	Renal Advantage (RAI)	Charleston	South Carolina
United States	Chattanooga Kidney Center	Chattanooga	Tennessee
United States	Silver Care Center	Cherry Hill	New Jersey
United States	Circle Medical Management	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Fort Smith Regional Dialysis Center	Fort Smith	Arkansas
United States	NRA Home	Frontenac	Missouri
United States	University of Texas Medical Branch	Galveston	Texas
United States	Renal Advantage (RAI)	Garden Grove	California
United States	Affiliated Home Dialysis	Glen Ellyn	Illinois
United States	Commonwealth Dialysis	Greenfield	Wisconsin
United States	Renal Advantage (RAI)	Hampton	Virginia
United States	Arkansas Nephrology Research Associates	Hot Springs	Arkansas
United States	RAI Palm Harbor, Outcomes Research Int'l	Hudson	Florida
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Dialysis Center of Lincoln	Lincoln	Nebraska
United States	University of Louisvile KDP	Louisville	Kentucky
United States	Nephrology, Inc.	Mishawaka	Indiana
United States	Satellite Healthcare/Wellbound	Mountain View	California
United States	Metabolism Associates - New Haven CAPD	New Haven	Connecticut
United States	Apollo Healthcare - Niagara Renal Center	Niagara Falls	New York
United States	Renal Advantage (RAI)	Oakland	California
United States	Renal Advantage	Omaha	Nebraska
United States	Virginia Commonwealth University/Medical College of Virginia	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Barlite SW Kidney Center	San Antonio	Texas
United States	Emory, Renal Care Partners of Dunwoody	Sandy Springs	Georgia
United States	Hortense and Louis Rubin Dialysis Center	Saratoga Springs	New York
United States	Northwest Kidney Centers	Seattle	Washington
United States	Kidney Center, Inc.	Simi Valley	California
United States	Community Physicians Dialysis Centers	Springfield	Ohio
United States	Washington University/Barnes Jewish Dialysis Center	St. Louis	Missouri
United States	Kansas Dialysis Services	Topeka	Kansas
United States	Munson Dialysis Center	Traverse City	Michigan
United States	Lillian Booth Dialysis Center	Westwood	New Jersey
United States	Wake Forest University/Piedmont Dialysis	Winston-Salem	North Carolina
United States	Renal Advantage (RAI)	Wyoming	Michigan
United States	Wellspan Dialysis	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NxStage Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalizations	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	duration of study participation	Yes