Home Nocturnal Trial Restarts – Participants Needed

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.

6 Responses to “Home Nocturnal Trial Restarts – Participants Needed”

  1. Lisa Calestino says:

    I am currently on Nxstage and have been for 3 yrs Before that I was on Nocturnal at Fresenius Warwick RI. I have been on dialysis for 30yrs and have tried every form of dialysis and transplant. I would be interested in being in the trial.

  2. We’ve been using the NxStage from day one since 2006 and have been trying to get on nocturnal ever since. We are in southern middle TN and travel several times per year to market the hand made pottery we make.

  3. rjberkowitz says:

    Jeff & Maggie, which dialysis center are you with? Even though there is no nocturnal indication for NxStage, there also is no contraindication. Any nephrologist should be able to prescribe nocturnal.

  4. We are with Fresenius Columbia and have been for about 3 years and DaVita Nashville before that. They keep saying they do not know who to contact for the “remote monitoring”. Our Dr. would like to see us start nocturnal. Every time we say something about it to the center they say “I will check into the NxStage nocturnal therapy and see what I can find out.” or something similar. The closest center I’ve been able to find that supports nocturnal with the NxStage is in St. Louis about 300 miles. We’ve been thinking about making the drive, just wish gas was not so high.

  5. rjberkowitz says:

    Most people who are on nocturnal do not need to be monitored. I am not. New York has regulations which require remote monitoring. Another option for you right now would be Bloomington, IN, but that not much better than St. Louis, except it’s in your time zone.

    Hopefully the current trial for the FDA will get completed soon and is sufficient for the FDA to approve the indication. We’ll see a loosening up of providers’ rules regarding nocturnal then.

  6. turner vaughan says:

    Been trying to sign up for the meet and greet in orlando but the site will not accept me as a single attendee. How do I go about making it happen?

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