FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome

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