The FREEDOM STUDY

The FREEDOM Study

12 Month Interim Results

A prospective study of Medicare patients who convert to home hemodialysis with the NxStage® System One™

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Study Design & Protocol1

The largest study of its kind:

  • Multi-center
  • Prospective
  • Observational
  • Matched Cohort
  • Maximum of 70 participating clinical centers
  • Minimum of 1-year follow-up

Patient Population:

  • Adult ESRD patients requiring dialysis
  • Medicare as primary payer

Primary Endpoint:

  • Hospitalization days per patient per year. Patients matched in 1:10 ratio to cohort from USRDS database.

Secondary Endpoints:

  • Quality of life (QOL) measures, clinical outcomes, non-treatment related costs, medication usage, urea kinetics, vascular access interventions.

Study Sponsor:

  • NxStage Medical, Inc., Lawrence, MA

 

 

Patients serve as their own baseline controls.

Data captured at baseline, month 4, and month 12.

Post-Dialysis Recovery Time

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

Depressive Symptoms (Beck Depression Inventory-II)

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

Anti-Hypertensive Medications

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

SF-36v2 Health Survey

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
Physical Functioning 51 57 56 0.002
Role-Physical 45 56 56 < 0.0001
Bodily Pain 57 61 64 0.03
General Health 44 51 49 < 0.0001
Vitality 44 55 54 < 0.0001
Role-Emotional 77 78 78 0.86
Mental Health 73 76 77 0.04
Social Functioning 63 73 73 < 0.0001

Sleep Quality (MOS Sleep Survey)

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
Sleep Disturbances 43 38 36 0.004
Snoring 44 39 37 0.08
Awaken Short of Breath or with a Headache 17 9 12 0.002
Daytime Somnolence 39 30 32 0.0001
Sleep Quantity (hours) 6.5 6.6 6.6 0.9
Optimal Sleep 42 37 38 0.7

Restless Legs Syndrome (IRLSSG Rating Scale)

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
Global Score 18 13 11 0.001
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

Principal Investigators and Investigation Sites

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

12 Month Interim Results Summary

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

References

  1. 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.
  2. 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.
  3. Finkelstein F, et al. Depression and end-stage renal disease: a therapeutic challenge. Kidney Int. 2008;74:843-845.
  4. Jaber B et al. Short Daily Hemodialysis Reduces The Need for Anit-Hypertensive Medications. Poster Presentation - American Society of Nephrology Renal Week, 2009.
  5. Rahman M, et al. Patterns of Antihypertensive Medication Use in Hemodialysis Patients. American Journal of Healthy-System Pharmacy. 2004;61(14).
  6. Finkelstein F. et al. Short Daily Hemodialysis Improves SF-36 Health Survey Domains. Poster presentation - Annual Dialysis Conference 2011.
  7. 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
  8. Jaber B, et al. Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances. CJASN 2011;6;1049-1056.
  9. 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.
  10. Winkelman JW, et al. Restless legs syndrome in end-stage renal disease. Am J Kidney Dis 1996;28:372– 378.
  11. 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

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