Kidney Failure, ChronicNCT00288613
FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
An observational study of Kidney Failure, Chronic and End Stage Renal Disease, Requiring Dialysis, run by NxStage Medical at 41 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, End Stage Renal Disease, Requiring Dialysis
- How many people
- 501 participants
- Where
- 41 sitesUnited States
- Study dates
- Jan 2006to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with ESRD who are candidates for daily hemodialysis with the NxStage System One and have Medicare as the primary payor.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Great Lakes Renal Network
Alma, Michigan, 48801
University of Colorado Hospital
Aurora, Colorado, 80045
Dialysis at Home, Inc
Brighton, Massachusetts, 02135
Renal Advantage (RAI)
Charleston, South Carolina, 29414
Chattanooga Kidney Center
Chattanooga, Tennessee, 37421
Silver Care Center
Cherry Hill, New Jersey, 07675
Circle Medical Management
Chicago, Illinois, 60607
Henry Ford Health System
Detroit, Michigan, 48202
Fort Smith Regional Dialysis Center
Fort Smith, Arkansas, 72901
NRA Home
Frontenac, Missouri, 63131
University of Texas Medical Branch
Galveston, Texas, 77555
Renal Advantage (RAI)
Garden Grove, California, 92843
Affiliated Home Dialysis
Glen Ellyn, Illinois, 60137
Commonwealth Dialysis
Greenfield, Wisconsin, 53220
Renal Advantage (RAI)
Hampton, Virginia, 23666
Arkansas Nephrology Research Associates
Hot Springs, Arkansas, 71901
RAI Palm Harbor, Outcomes Research Int'l
Hudson, Florida, 34667
Indiana University Medical Center
Indianapolis, Indiana, 46202
Dialysis Center of Lincoln
Lincoln, Nebraska, 66510
University of Louisvile KDP
Louisville, Kentucky, 40202
Nephrology, Inc.
Mishawaka, Indiana, 46545
Satellite Healthcare/Wellbound
Mountain View, California, 94041
Metabolism Associates - New Haven CAPD
New Haven, Connecticut, 06511
Apollo Healthcare - Niagara Renal Center
Niagara Falls, New York, 14304
Renal Advantage (RAI)
Oakland, California, 94612
Renal Advantage
Omaha, Nebraska, 68198
Virginia Commonwealth University/Medical College of Virginia
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Barlite SW Kidney Center
San Antonio, Texas, 78224
Emory, Renal Care Partners of Dunwoody
Sandy Springs, Georgia, 30350
Hortense and Louis Rubin Dialysis Center
Saratoga Springs, New York, 12866
Northwest Kidney Centers
Seattle, Washington, 98122
Kidney Center, Inc.
Simi Valley, California, 93065
Community Physicians Dialysis Centers
Springfield, Ohio, 45505
Washington University/Barnes Jewish Dialysis Center
St Louis, Missouri, 63108
Kansas Dialysis Services
Topeka, Kansas, 66606
Munson Dialysis Center
Traverse City, Michigan, 49684
Lillian Booth Dialysis Center
Westwood, New Jersey, 07675
Wake Forest University/Piedmont Dialysis
Winston-Salem, North Carolina, 27157
Renal Advantage (RAI)
Wyoming, Michigan, 49509
Wellspan Dialysis
York, Pennsylvania, 15198
About this study
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.
Read the 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.
- Keywords
- ESRD, Daily Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations
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
Measured: duration of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- NxStage Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand L. Jaber, MD, FASN, Principal investigator, Unaffilated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288613
- Sponsor's protocol ID
- CP0009
- Status last verified
- Jul 2014
- First submitted
- 6 Feb 2006
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheetham MS, Ethier I, Krishnasamy R, Cho Y, Palmer SC, Johnson DW, Craig JC, Stroumza P, Frantzen L, Hegbrant J, Strippoli GF. Home versus in-centre haemodialysis for people with kidney failure. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD009535. doi: 10.1002/14651858.CD009535.pub3.
PubMed 38588450Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.
PubMed 22622497Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.
PubMed 21415315Jaber BL, Finkelstein FO, Glickman JD, Hull AR, Kraus MA, Leypoldt JK, Liu J, Gilbertson D, McCarthy J, Miller BW, Moran J, Collins AJ; FREEDOM Study Group. Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis. 2009 Feb;53(2):310-20. doi: 10.1053/j.ajkd.2008.07.013. Epub 2008 Sep 27.
PubMed 18823688
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
- ClinicalTrials.gov ID
- NCT00288613
- Acronym / sponsor ID
- CP0009
- Keywords
- ESRD, Daily Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- NxStage MedicalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with ESRD who are candidates for daily hemodialysis with the NxStage System One and have Medicare as the primary payor.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 38588450Cheetham MS, Ethier I, Krishnasamy R, Cho Y, Palmer SC, Johnson DW, Craig JC, Stroumza P, Frantzen L, Hegbrant J, Strippoli GF. Home versus in-centre haemodialysis for people with kidney failure. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD009535. doi: 10.1002/14651858.CD009535.pub3.
- Derived from this study: PubMed 22622497Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.
- Derived from this study: PubMed 21415315Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.
- Derived from this study: PubMed 18823688Jaber BL, Finkelstein FO, Glickman JD, Hull AR, Kraus MA, Leypoldt JK, Liu J, Gilbertson D, McCarthy J, Miller BW, Moran J, Collins AJ; FREEDOM Study Group. Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis. 2009 Feb;53(2):310-20. doi: 10.1053/j.ajkd.2008.07.013. Epub 2008 Sep 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand L. Jaber, MD, FASN principal investigator
Unaffilated
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and End Stage Renal Disease, Requiring Dialysis, run by NxStage Medical at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalizations (time frame: duration of study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288613, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.