deltatrials
Completed OBSERVATIONAL NCT00288613

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

Sponsor: NxStage Medical

Updated 8 times since 2017 Last updated: Jul 22, 2014 Started: Jan 31, 2006 Primary completion: Nov 30, 2013 Completion: Nov 30, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on End Stage Renal Disease, Requiring Dialysis and Kidney Failure, Chronic, this trial is completed. The trial is conducted by NxStage Medical and has accumulated 8 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed

  2. Sep 2024 — Sep 2025 [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. Jun 2018 — Jan 2021 [monthly]

    Completed

Show 3 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: PHASE4None

  2. Feb 2017 — Apr 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Jan 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • NxStage Medical
Data source: NxStage Medical

For direct contact, visit the study record on ClinicalTrials.gov .