12 Month Interim Results
A prospective study of Medicare patients who convert to home hemodialysis with the NxStage® System One™
Study Design & Protocol1
The largest study of its kind:
- Matched Cohort
- Maximum of 70 participating clinical centers
- Minimum of 1-year follow-up
- Adult ESRD patients requiring dialysis
- Medicare as primary payer
- Hospitalization days per patient per year. Patients matched in 1:10 ratio to cohort from USRDS database.
- Quality of life (QOL) measures, clinical outcomes, non-treatment related costs, medication usage, urea kinetics, vascular access interventions.
- NxStage Medical, Inc., Lawrence, MA
Patients serve as their own baseline controls.
Data captured at baseline, month 4, and month 12.
Short Daily Hemodialysis (SDHD) Reduces Post-Dialysis Time to Recovery2
Post-dialysis fatigue, often described as a "washed-out" feeling, frequently limits dialysis patient's activity levels for many hours post treatment, impacting quality of life.2
SDHD Reduces Depressive Symptoms (BDI Score)2
Depression is generally agreed to be the most common psychological problem presented by dialysis patients, with a reported prevalence of 20-30% of patients with renal failure.3
SDHD Reduces the Need for Anti-Hypertensive Medications4
Hypertension is very common and often poorly controlled in patients undergoing long-term hemodialysis therapy, contributing to increased cardiovascular morbidity in this population.5
SDHD Improves Mental & Physical Health (SF-36 Scores)6
As reported in the Dialysis Outcomes and Practice Patterns Study (DOPPS), lower health related quality of life scores in dialysis patients have been strongly associated with significantly higher risk of death and hospitalizations.7
|SF-36 Domain (N = 155)||Baseline||Month-4||Month-12||Global P value|
|Physical component scale (PCS)||34||38||38||< 0.0001|
|Mental component scale (MCS)||50||52||52||0.01|
|General Health||44||51||49||< 0.0001|
|Social Functioning||63||73||73||< 0.0001|
SDHD Improves Sleep Quality (MOS Sleep Survey Scores)8
Poor sleep quality in the HD population has been linked to lower Quality of Life measures and increased mortality risk.9
|MOS Sleep Scale (N = 127)||Baseline||Month-4||Month-12||P value|
|Sleep Problems Index I||39||33||33||0.001|
|Sleep Problems Index II||41||35||34||< 0.001|
|Adequacy of Sleep||49||52||53||0.23|
|Awaken Short of Breath or with a Headache||17||9||12||0.002|
|Sleep Quantity (hours)||6.5||6.6||6.6||0.9|
Improves Restless Legs Syndrome (IRLSSG scales)8
Restless legs syndrome is a movement disorder characterized by an "achy" or "crawling" sensation, usually in the lower extremities.10 Symptoms of restless legs syndrome in the long-term hemodialysis population have a reported prevalence of 12-30%.11
|IRLS Subscales (N = 46)||Baseline||Month-12||Month-12||P value|
|Symptoms Score||12||8||8||< 0.001|
|Impact on Daily Living Subscale||3||3||2||0.55|
|Presence of RLS (N = 127)||Baseline||Month-12||Month-12||P value|
|No. of subjects experiencing RLS||46 (36%)||38 (32%)||29 (26%)||0.0495|
Following is a list of principal investigators and investigation sites that have enrolled FREEDOM Study patients
Rachid Daoui, MD, Rubin Dialysis, NY
Dana Rabideau, MD, Fort Smith Dialysis, AR
Marvin Sinsakul, MD, Circle Medical, IL
Scott Solcher, MD, Kansas Dialysis, KS
Tim Govaerts, MD, Dialysis Center of Lincoln, NE
Michael Kraus, MD, Indiana University, IN
Chandra Mohan, MD, Wellspan Dialysis, PA
Todd Gehr, MD, VCU/RAI Richmond, VA
Martin Gelman, MD, Personal Dialysis, MA
Mirel Abramovici, MD, Lillian Booth Dialysis Center, NJ
Andrea Iannuzzelli, DO, Silver Dialysis, Inc., NJ
Brent Miller, MD, Barnes Jewish/Wash Univ., MO
Brigitte Schiller, MD, Satellite Healthcare/Wellbound, CA
Fred Finkelstein, MD, Metabolism Associates, CT
Pius Kurian, MD, DaVita Fairborn, OH
Robert Szewc, MD, Barlite SW Kidney Center, TX
Sujatha Addagatla, MD, Niagara Renal Center, NY
Claude Galphin, MD, Chattanooga Kidney Center
William Elliott, MD, DaVita Bluemound Dialysis, WI
James L. Porile, MD, Nephrology, Inc., IN
Troy Plumb, MD, RAI Omaha, NE
Ahmet Sevimli, MD, Munson Dialysis Center, MI
Bessie Young, MD, MPH, Northwest Kidney Centers, WA
James Novak, MD, Henry Ford Hospital/Greenfield Health Systems, MI
George Aronoff, MD, Univ. of Louisville, KY
Victor Rozas, MD, Great Lakes Renal, MI
Prakas D'Cunha, MD, RAI Palm Harbor, FL
Amy Williams, MD, Mayo Clinic, MN
Isaac Teitelbaum, MD, Univ. Colorado, CO
Heidi Joist, MD, RAI Frontenac, MO
Kant Tucker, MD, Kidney Centers Inc., CA
Janice Lea, MD, Emory University/RCP Sandy Springs, GA
John Burkart, MD, Wake Forest Univ./Piedmont Dialysis, NC
Michael Sean Gersch, MD, Arkansas Nephrology Research Assoc., AR
Norwood Hamilton, MD, RAI- Charlie Hall, SC
Robert Doud, MD, RAI Oakland, CA
Robert Pusateri, MD, RAI-Mercury Blvd, VA
Hong Kim, MD, RAI Goldenwest, CA
Kseniya Filippova, MD, RAI Clyde Park, MI
|Interim Measure||Baseline||Month-12||P value|
|Beck Depression Inventory Score2||11.2||7.5||< 0.001|
|Post Dialysis Recovery Time (min)2||476||63||< 0.001|
|# of Prescribed Anti-Hypertensive Medications4||1.7||1.0||< 0.0001|
|% of Patients NOT Prescribed Anti-Hypertensive Medication4||21%||47%||< 0.002|
|SF36 - Physical component score (PCS)6||34||38||< 0.0001|
|SF36 - Mental component score (MCS)6||50||52||0.01|
|MOS Sleep Scale - Sleep Problems Index I8||39||33||0.001|
|MOS Sleep Scale - Sleep Problems Index II8||41||34||< 0.001|
|% of Patients Reporting Symptoms of Restless Legs Syndrome8||35%||26%||0.0495|
- Jaber B, et al. Scope and Design of the Following Rehabilitation, Economics and Everyday- Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis 2009;53:310-320.
- Jaber B, et al. Effect of Daily Hemodialysis on Depressive Symptoms and Postdialysis Recovery Time: Interim Report From The FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcomes Measurements) Study. Am J Kidney Dis 2010;56:531-539.
- Finkelstein F, et al. Depression and end-stage renal disease: a therapeutic challenge. Kidney Int. 2008;74:843-845.
- Jaber B et al. Short Daily Hemodialysis Reduces The Need for Anit-Hypertensive Medications. Poster Presentation - American Society of Nephrology Renal Week, 2009.
- Rahman M, et al. Patterns of Antihypertensive Medication Use in Hemodialysis Patients. American Journal of Healthy-System Pharmacy. 2004;61(14).
- Finkelstein F. et al. Short Daily Hemodialysis Improves SF-36 Health Survey Domains. Poster presentation - Annual Dialysis Conference 2011.
- Mapes D, et al. Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney International 2003;64;339–349
- Jaber B, et al. Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances. CJASN 2011;6;1049-1056.
- Elder SJ, et al. Sleep quality predicts quality of life and mortality risk in haemodialysis patients: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2008;23;998–1004.
- Winkelman JW, et al. Restless legs syndrome in end-stage renal disease. Am J Kidney Dis 1996;28:372– 378.
- Unruh M, et al. Restless Legs Symptoms Among Incident Dialysis Patients: Association With Lower Quality of Life and Shorter Survival. Am J Kidney Dis 2004;43:900-909.
Despite the health benefits that daily, more frequent home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of daily, more frequent home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream, and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.
For more information on the FREEDOM Study, visit www.clinicaltrials.gov