According to information found on the Governments Clinical Trials website, NxStage Medical’s trial for nocturnal home hemodialysis is restarting in order to get an indication for the Food & Drug Administration. Participants are needed for the five clinics in the trial. Home Dialyzors United learned at a meeting with the FDA’s Gastroenterology and Renal Devices division that 35 – 50 participants must be recruited. The five participating clinics in the trial are Wellbound in Northern California, DaVita Grapevine (TX), DaVita Bluemound (WI), Fresenius Wichita (KS) and Barnes-Jewish Hospital in St. Louis.
Independent of NxStage, HDU had contacted the FDA to begin discussions about home nocturnal dialysis. HDU has had several discussions with the FDA and has offered itself to be a resource. HDU has already informed the FDA that it will be collecting anecdotal data, consisting of stories of existing nocturnal patient and those who desire to do nocturnal. It is HDU’s opinion that patients must get involved with the big issues affecting our lives.
As part of its support for the trial, HDU will match up trial participants with HDU Buddies who are already doing nocturnal if the patients so desire. HDU will also be creating informational pieces and videos to support the trial.