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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288613
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
NxStage Medical

Tracking Information
First Submitted Date February 6, 2006
First Posted Date February 8, 2006
Last Update Posted Date July 24, 2014
Study Start Date January 2006
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2014)
Hospitalizations [ Time Frame: duration of study participation ]
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
Official Title FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Kidney Failure, Chronic
  • End Stage Renal Disease, Requiring Dialysis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2014)
501
Original Enrollment
 (submitted: February 6, 2006)
500
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00288613
Other Study ID Numbers CP0009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NxStage Medical
Study Sponsor NxStage Medical
Collaborators Not Provided
Investigators
Principal Investigator: Bertrand L. Jaber, MD, FASN Unaffilated
PRS Account NxStage Medical
Verification Date July 2014