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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NxStage Medical
ClinicalTrials.gov Identifier:
NCT00288613
First received: February 6, 2006
Last updated: July 22, 2014
Last verified: July 2014
  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 4

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

Resource links provided by NLM:


Further study details as provided by NxStage Medical:

Primary Outcome Measures:
  • Hospitalizations [ Time Frame: duration of study participation ] [ Designated as safety issue: Yes ]
    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


Enrollment: 501
Study Start Date: January 2006
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 41 Study Locations
Sponsors and Collaborators
NxStage Medical
Investigators
Principal Investigator: Bertrand L. Jaber, MD, FASN Unaffilated
  More Information

No publications provided by NxStage Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00288613     History of Changes
Other Study ID Numbers: CP0009
Study First Received: February 6, 2006
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on October 01, 2014