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

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.

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