First patient enrolled in NxStage's home daily hemodialysis study

By E. Janene Geiss

Philadelphia, Feb. 2 - NxStage Medical, Inc. announced Thursday 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, 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, according to a company news release.

The study will quantify the impact of daily therapy on hospitalization rates and total annual costs of care for Medicare beneficiaries undergoing hemodialysis, officials said.

Published U.S. government data estimates the total health care cost burden of a dialysis patient at $65,000 annually with dialysis services representing about 25% of this cost while the cost of hospitalizations, drugs and physician fees make up more than 50%, officials said.

"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," Jeffrey Burbank, NxStage's chief executive officer, said in the release.

The Freedom study is a prospective, multi-center, observational study that 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," said Bertrand Jaber, scientific adviser of the study and assistant chair of medicine at Caritas St. Elizabeth's Hospital in Brighton, Mass., in the release. "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."

The first patient was enrolled at Hortense and Louis Rubin Dialysis Center in Troy, N.Y.

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.

Additional clinical sites will be initiated over the coming months, officials said.

NxStage is a medical device company based in Lawrence, Mass., that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease and acute kidney failure.

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