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Dialysis Discussion => Dialysis: General Discussion => Topic started by: okarol on September 23, 2008, 01:29:02 PM

Title: FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome
Post by: okarol on September 23, 2008, 01:29:02 PM
CLINICAL TRIALS:  FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

This study is currently recruiting participants.
Verified by NxStage Medical, May 2008

Sponsored by:    NxStage Medical
Information provided by:    NxStage Medical
ClinicalTrials.gov Identifier:    NCT00288613
  Purpose

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.

Condition    Phase
Kidney Failure, Chronic
End Stage Renal Disease, Requiring Dialysis
   Phase IV

MedlinePlus related topics:      Dialysis    Kidney Failure    Rehabilitation   

U.S. FDA Resources

Study Type:      Observational
Study Design:      Case-Only, Prospective
Official Title:      FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

Further study details as provided by NxStage Medical:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:      500
Study Start Date:      January 2006

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.
  Eligibility
Ages Eligible for Study:      18 Years and older
Genders Eligible for Study:      Both
Accepts Healthy Volunteers:      No
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.

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288613

Locations
United States, Arkansas
   Fort Smith Regional Dialysis Center           Recruiting
         Fort Smith, Arkansas, United States, 72901
         Contact: Nancy Bryant, RN, CNN     479-709-7451       
         Principal Investigator: Dana P. Rabideau, MD           
United States, California
   Satellite Healthcare/Wellbound           Recruiting
         Mountain View, California, United States, 94041
         Contact: Sheila J. Doss, RN, CNN,CCRA     650-404-3621     dosss@satellitehealth.com   
         Principal Investigator: Brigitte Schiller-Moran, MD           
United States, Connecticut
   Metabolism Associates - New Haven CAPD           Recruiting
         New Haven, Connecticut, United States, 06511
         Contact: Maureen McPherson, RN     203-773-0853       
         Principal Investigator: Fredric O Finkelstein, MD           
United States, Illinois
   Circle Medical Management           Recruiting
         Chicago, Illinois, United States, 60607
         Contact: Janice Ferrell, RN     312-829-1424 ext 228     janicef@covad.net   
         Principal Investigator: Marvin Sinsakul, MD           
United States, Indiana
   Indiana University Medical Center           Recruiting
         Indianapolis, Indiana, United States, 46202
         Contact: Karen Graves, RN     317-278-6962     kargrave@iupui.edu   
         Principal Investigator: Michael Kraus, MD           
   Nephrology, Inc.           Recruiting
         Mishawaka, Indiana, United States, 46545
         Contact: Cindy Nagy, RN, OCN     574-273-6787 ext 5004     cnagy@nephinc.com   
         Principal Investigator: James L. Porile, MD           
United States, Kansas
   Kansas Dialysis Services           Recruiting
         Topeka, Kansas, United States, 66606
         Contact: Cindy Zielke, RN     785-234-2277     cindyz@kds.bz   
         Contact: Sandra Bagg, RN     785-234-2277     sandra@kds.bz   
         Principal Investigator: Scott Solcher, MD           
United States, Kentucky
   University of Louisvile KDP           Recruiting
         Louisville, Kentucky, United States, 40202
         Contact: Melissa Jordan, BA     502-852-2290     mjjord01@gwise.louisville.edu   
         Principal Investigator: George Aronoff, MD           
United States, Massachusetts
   Dialysis at Home, Inc           Recruiting
         Brighton, Massachusetts, United States, 02135
         Contact: Martin L. Gelman, MD     617-782-4544     Gelman85@aol.com   
         Principal Investigator: Martin L Gelman, MD           
United States, Michigan
   Munson Dialysis Center           Recruiting
         Traverse City, Michigan, United States, 49684
         Contact: Janine Diebel, RN     231-935-0460     jdiebel@mhc.net   
         Principal Investigator: Ahmet Sevimli, MD           
   Henry Ford Health System           Recruiting
         Detroit, Michigan, United States, 48202
         Contact: JoAnne Keller, RN     313-916-7080     jkeller1@hfhs.org   
         Principal Investigator: Nizar M. Attallah, MD           
   Great Lakes Renal Network           Recruiting
         Alma, Michigan, United States, 48801
         Contact: Rita Martin, RN         rita.martin@midmichigan.org or rmartin@gratiohealth.com   
         Principal Investigator: Victor Rozas, MD           
United States, Missouri
   Washington University/Barnes Jewish Dialysis Center           Recruiting
         St. Louis, Missouri, United States, 63108
         Contact: Janet Riley, RN     314-362-8274     jriley@im.wustl.edu   
         Principal Investigator: Brent W Miller, MD           
United States, Nebraska
   Dialysis Center of Lincoln           Recruiting
         Lincoln, Nebraska, United States, 66510
         Contact: Jean Garrison, RN     402-489-5339     jgarrison@dialysisnebraska.org   
         Principal Investigator: Timothy Govaerts, MD           
   Renal Advantage           Recruiting
         Omaha, Nebraska, United States, 68198
         Contact: Theresa Herring, RN     402-558-3284     theresa.herring@renaladvantage.com   
         Principal Investigator: Gerald Groggel, MD           
United States, New Jersey
   Silver Care Center           Recruiting
         Cherry Hill, New Jersey, United States, 07675
         Contact: Kathleen Neugent, RN     856-616-7338     kneugent@silvercarecenter.com   
         Principal Investigator: Andrea Iannuzzelli, DO           
   Lillian Booth Dialysis Center           Recruiting
         Westwood, New Jersey, United States, 07675
         Contact: Kimberly Davis     201-664-6649     kdavis@pvhospital.org   
         Principal Investigator: Mirel Abramovici, MD           
United States, New York
   Hortense and Louis Rubin Dialysis Center           Recruiting
         Saratoga Springs, New York, United States, 12866
         Contact: Shari Meola, RN     518-587-1919       
         Principal Investigator: Rachid Daoui, MD           
         Sub-Investigator: Christopher D. Hoy, MD           
   Apollo Healthcare - Niagara Renal Center           Recruiting
         Niagara Falls, New York, United States, 14304
         Contact: Theressa Sitgreaves, RN BNSC CNN     716-298-4195     tsitgreaves@apollohealth.us   
         Principal Investigator: Sujatha Addagatla, MD           
United States, Ohio
   Community Physicians Dialysis Centers           Recruiting
         Springfield, Ohio, United States, 45505
         Contact: Susan L Powderly, RN     937-879-0433     sue.powderly@health-partners.org   
         Principal Investigator: Pius Kurian, MD           
United States, Pennsylvania
   Wellspan Dialysis           Recruiting
         York, Pennsylvania, United States, 15198
         Contact: Linda Eberle     717-851-6513     leberle2@wellspan.org   
         Principal Investigator: Chandra Mohan, MD           
United States, Tennessee
   Chattanooga Kidney Center           Recruiting
         Chattanooga, Tennessee, United States, 37421
         Contact: John Burke     423-648-4900     jburke@ckcdialysis.com   
         Principal Investigator: Claude M Galphin, MD           
United States, Texas
   Barlite SW Kidney Center           Terminated
         San Antonio, Texas, United States, 78224
   University of Texas Medical Branch           Terminated
         Galveston, Texas, United States, 77555
United States, Virginia
   Virginia Commonwealth University/Medical College of Virginia           Recruiting
         Richmond, Virginia, United States, 23298
         Contact: Judy Pulliam     804-828-9684     jlpulliam@vcu.edu   
         Principal Investigator: Todd Gehr, MD           
United States, Washington
   Northwest Kidney Centers           Recruiting
         Seattle, Washington, United States, 98122
         Contact: Terri V Aguiling, RN, BSN     206-292-2771 ext 2139     aguilingt@nwkidney.org   
         Principal Investigator: Bessie A. Young, MD, MPH           
United States, Wisconsin
   Commonwealth Dialysis           Recruiting
         Greenfield, Wisconsin, United States, 53220
         Contact: Gail Scott, RN     414-281-6806     gscott@thekidneyinstitute.com   
         Principal Investigator: William C Elliott, MD           

Sponsors and Collaborators
NxStage Medical

Investigators
Principal Investigator:        Bertrand L. Jaber, MD, FASN        Unaffilated     

Sponsors and Collaborators
NxStage Medical

Investigators
Principal Investigator:        Bertrand L. Jaber, MD, FASN        Unaffilated   
  More Information


Responsible Party:      NxStage Medical, Inc. ( Paul Clark, Director of Clinical and Regulatory Affairs )
Study ID Numbers:      CP0009
First Received:      February 6, 2006
Last Updated:      May 20, 2008
ClinicalTrials.gov Identifier:      NCT00288613
Health Authority:      United States: Institutional Review Board

Keywords provided by NxStage Medical:
ESRD 
Daily Hemodialysis 
Hemodialysis 
Kidney Failure 
Kidney Disease 

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
      
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 23, 2008
http://clinicaltrials.gov/ct2/show/NCT00288613