I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: General Discussion => Topic started 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