First Patient Enrolled in NxStage’s FREEDOM Home Daily Hemodialysis Study
Post-market study to quantify clinical benefits and cost savings of daily home-hemodialysis
LAWRENCE, Mass., Feb. 2 /PRNewswire-FirstCall/ – NxStage Medical, Inc.
(Nasdaq: NXTM), a manufacturer of innovative, portable home hemodialysis systems, announced the enrollment of the first patient in its FREEDOM Study. Sponsored by NxStage, and implemented in collaboration with up to 70 U.S. dialysis clinics and the United States Renal Data System (USRDS), FREEDOM (Following Rehabilitation, Economics, and Everyday Dialysis Outcome Measurements) is a prospective study to quantify the clinical benefits and cost savings of daily therapy administered to Medicare patients with the NxStage System One versus conventional thrice-weekly dialysis.
Importantly, it will quantify the impact of daily therapy on hospitalization rates and total annual costs of care for Medicare beneficiaries undergoing hemodialysis. Published U.S. government data estimates the total health care cost burden of a dialysis patient at $65,000 annually, with dialysis services representing approximately 25% of this cost, while the cost of hospitalizations, drugs and physician fees make up more than 50%.
“We believe this study will demonstrate that daily home dialysis therapy, which has been shown to improve clinical outcomes, will also significantly reduce the total costs associated with dialysis patients. This should lead to greater utilization by health care providers of home and daily hemodialysis with the NxStage System One,” stated Mr. Jeffrey Burbank, NxStage’s Chief Executive Officer. “We are encouraged by the results of a recent internal study by Kaiser Permanente demonstrating that home daily hemodialysis produced an approximate $10,000 savings per year per patient versus traditional in-center therapy. As a result, Kaiser Permanente now encourages daily hemodialysis among its beneficiaries. We expect other providers to follow suit as we capture ongoing clinical and economic data and present it to the medical community,” added Mr. Burbank.
The FREEDOM Study is a prospective, multi-center, observational study, which will enroll up to 500 Medicare patients in up to 70 clinical centers over a two year period. “FREEDOM demonstrates a clear commitment by NxStage to better characterize the cost-effectiveness of daily home hemodialysis, using the NxStage System One,” stated Bertrand Jaber, MD, Scientific Advisor of the study and Assistant Chair of Medicine at Caritas St. Elizabeth’s Hospital in Brighton, Massachusetts. “The value of this study is demonstrated by its comprehensive aims, which are to quantify the impact of daily therapy on hospitalization and total economic costs, but also to confirm the tremendous reported potential benefits of daily therapy on patient quality of life and rehabilitation,” added Dr. Jaber. The first patient was enrolled at Hortense and Louis Rubin Dialysis Center, in Troy, New York.
This is the first time that an outcomes study will prospectively compare economic outcomes of more frequent, or “daily,” hemodialysis with those of a matched cohort of thrice-weekly in-center patients. “The FREEDOM Study will compare patients using the NxStage System One with a matched cohort of patients from the USRDS patient database treated with traditional in-center thrice weekly dialysis, to help define differences in the cost of care and patient outcomes between the daily home setting and the dialysis clinic setting,” said Allan Collins, MD, FACP, Director of the Chronic Disease Research Group and Professor of Medicine at the University of Minnesota. “This study will provide a practical method to provide further insights into more frequent dialysis and its cost-effectiveness,” added Dr. Collins.
The USRDS database has long been considered one of the leading data sources on the demographics, outcomes, and economic costs of dialysis. Comparing the study group of patients using the NxStage System One to a USRDS database group matched in terms of demographics, co-morbidities, geography, number of years on dialysis, and other key factors, will allow a valuable comparison to be made without the time and cost challenges of a crossover study, in which patients would be followed for a given time on each type of therapy.
Additional clinical sites will be initiated over the coming months. Physicians, dialysis centers, or patients interested in participating in the FREEDOM study should contact Christine Allen, Director of Clinical Research at NxStage at 978-687-4718. More detailed information on the study protocol and entry criteria can be found at
http://www.clinicaltrials.gov under Listings.