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

NCT00288613 | Completed DMC

• 1 other identifier: CP0009
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 41

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.

Conditions

Kidney Failure, Chronic; End Stage Renal Disease, Requiring Dialysis

Keywords

ESRD; Daily Hemodialysis; Hemodialysis; Kidney Failure; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• NxStage Medical: lead

Study Sites (41)

Fort Smith Regional Dialysis Center

Fort Smith, Arkansas, 72901, United States

Location

Arkansas Nephrology Research Associates

Hot Springs, Arkansas, 71901, United States

Location

Renal Advantage (RAI)

Garden Grove, California, 92843, United States

Location

Satellite Healthcare/Wellbound

Mountain View, California, 94041, United States

Location

Renal Advantage (RAI)

Oakland, California, 94612, United States

Location

Kidney Center, Inc.

Simi Valley, California, 93065, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Metabolism Associates - New Haven CAPD

New Haven, Connecticut, 06511, United States

Location

RAI Palm Harbor, Outcomes Research Int'l

Hudson, Florida, 34667, United States

Location

Emory, Renal Care Partners of Dunwoody

Sandy Springs, Georgia, 30350, United States

Location

Circle Medical Management

Chicago, Illinois, 60607, United States

Location

Affiliated Home Dialysis

Glen Ellyn, Illinois, 60137, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Nephrology, Inc.

Mishawaka, Indiana, 46545, United States

Location

Kansas Dialysis Services

Topeka, Kansas, 66606, United States

Location

University of Louisvile KDP

Louisville, Kentucky, 40202, United States

Location

Dialysis at Home, Inc

Brighton, Massachusetts, 02135, United States

Location

Great Lakes Renal Network

Alma, Michigan, 48801, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Munson Dialysis Center

Traverse City, Michigan, 49684, United States

Location

Renal Advantage (RAI)

Wyoming, Michigan, 49509, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NRA Home

Frontenac, Missouri, 63131, United States

Location

Washington University/Barnes Jewish Dialysis Center

St Louis, Missouri, 63108, United States

Location

Dialysis Center of Lincoln

Lincoln, Nebraska, 66510, United States

Location

Renal Advantage

Omaha, Nebraska, 68198, United States

Location

Silver Care Center

Cherry Hill, New Jersey, 07675, United States

Location

Lillian Booth Dialysis Center

Westwood, New Jersey, 07675, United States

Location

Apollo Healthcare - Niagara Renal Center

Niagara Falls, New York, 14304, United States

Location

Hortense and Louis Rubin Dialysis Center

Saratoga Springs, New York, 12866, United States

Location

Wake Forest University/Piedmont Dialysis

Winston-Salem, North Carolina, 27157, United States

Location

Community Physicians Dialysis Centers

Springfield, Ohio, 45505, United States

Location

Wellspan Dialysis

York, Pennsylvania, 15198, United States

Location

Renal Advantage (RAI)

Charleston, South Carolina, 29414, United States

Location

Chattanooga Kidney Center

Chattanooga, Tennessee, 37421, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Barlite SW Kidney Center

San Antonio, Texas, 78224, United States

Location

Renal Advantage (RAI)

Hampton, Virginia, 23666, United States

Location

Virginia Commonwealth University/Medical College of Virginia

Richmond, Virginia, 23298, United States

Location

Northwest Kidney Centers

Seattle, Washington, 98122, United States

Location

Commonwealth Dialysis

Greenfield, Wisconsin, 53220, United States

Location

Related Publications (4)

• Cheetham MS, Ethier I, Krishnasamy R, Cho Y, Palmer SC, Johnson DW, Craig JC, Stroumza P, Frantzen L, Hegbrant J, Strippoli GF. Home versus in-centre haemodialysis for people with kidney failure. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD009535. doi: 10.1002/14651858.CD009535.pub3.

  PMID: 38588450 DERIVED

• Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.

  PMID: 22622497 DERIVED

• Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.

  PMID: 21415315 DERIVED

• Jaber BL, Finkelstein FO, Glickman JD, Hull AR, Kraus MA, Leypoldt JK, Liu J, Gilbertson D, McCarthy J, Miller BW, Moran J, Collins AJ; FREEDOM Study Group. Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis. 2009 Feb;53(2):310-20. doi: 10.1053/j.ajkd.2008.07.013. Epub 2008 Sep 27.

  PMID: 18823688 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand L. Jaber, MD, FASN

  Unaffilated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 8, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (41)