NxStage Medical, Inc. a leading manufacturer of innovative dialysis products, announced the latest interim results from its ongoing Freedom study which show an increase in overall quality of life benefits, significant improvement in overall sleep quality and a marked improvement in Restless Legs Syndrome (RLS) symptoms experienced by patients after 12 months of daily home haemodialysis with the NxStage System One.

The study results were presented during the Annual Dialysis Conference in Phoenix, Arizona. The ongoing Freedom study is the largest study of its kind to measure the clinical and economic benefits of daily home haemodialysis treatment, as compared to conventional, thrice-weekly in-centre haemodialysis treatment for patients requiring dialysis therapy.

“These latest 12-month results are extremely encouraging. The analysis shows the quality of life benefits eligible patients experience at month four continue and sometimes strengthen by month 12. These benefits are dramatic and can be truly life-changing,” said Dr Frederic Finkelstein MD, Chief of Nephrology at the Hospital of St. Raphael in New Haven, Conn. and Clinical Professor of Medicine at Yale University Medical School as well as an investigator on the Freedom study. “These improvements in mental and physical scores suggest that daily haemodialysis leads to an overall healthier and happier patient.”

The interim analysis of the Freedom study shows that daily home haemodialysis is associated with clear improvements in quality of life benefits sustained throughout a 12-month period, as measured by the SF-36v2 Health Survey.

Results show: significant improvements in both mental health scores (Mental Component Summary) and physical health scores (Physical Component Summary) from baseline to month 12. (MCS: P=0.01; PCS<0.0001). Seven out of eight individual SF-36 domains - including physical functioning, bodily pain, general health, vitality, mental health and social functioning - showed clinically meaningful improvements.

RLS is a distressing neurological disorder characterized by an uncomfortable sensation in the legs, with an irresistible urge to move them. According to various studies, as many as 62% of End Stage Renal Disease (ESRD) patients suffer from RLS which can disrupt their sleep. Additional interim results from the Freedom study compared patients' responses to the Medical Outcomes Study (MOS) Sleep Survey and the International RLS Study Group Rating Scale (IRLS) at baseline and 12 months.

The 12-month data showed: overall sleep quality (as measured by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month 12. (Index I: P=0.001; Index II: P<0.001), significant improvement in three of the individual sleep scales - sleep disturbances, daytime somnolence, and awaken short of breath or with a headache. A sustained improvement in the IRLS global score at four and 12 months compared to baseline (P<0.001) and significant reduction in the percentage of patients who experienced RLS after 12 months (35% vs 26%, p = 0.05). Of those patients experiencing RLS, there was a trend towards a reduction in the percentage of patients with moderate to severe RLS (59% vs 43%, p=0.06).

“The Freedom study is an important part of our ongoing commitment to enhance access to home haemodialysis,” stated Joseph Turk, president North America of NxStage Medical. “We are delighted that the results continue to reinforce the life-changing benefits of daily home haemodialysis with the NxStage System One.”

These 12-month interim results from the Freedom study have been accepted for publication in the Clinical Journal of the American Society of Nephrology (CJASN).

All daily home haemodialysis patients in the Freedom study use the NxStage System One as their treatment delivery system, and all have Medicare as their primary insurance payer.

NxStage Medical, Inc. is a medical device company that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease, or ESRD, and acute kidney failure.