Slow FDA Response is Hurting Nocturnal Home HD

This blog post was made by Dori Schatell, MS, Executive Director, Medical Education Institute on November 13th, 2014.
Slow FDA Response is Hurting Nocturnal Home HD

If you’ve been following this blog space for the past year and a half or so, you know why we fervently believe that longer and slower HD are better. (Missed it? Check out this and this, to start…) And, since I’m heading to ASN this week, this means it’s been about four years since NxStage submitted the System One cycler to the U.S. Food and Drug Administration (FDA) to try to get a new indication for nocturnal home use. Four years. An entire Presidency’s worth of delays, additional studies, conference calls (I’ve been on some with the Home Dialysis Alliance)—and more delays.

According to the FDA website, companies submit medicines or devices to get approval for “indications for use.” Approved indications become part of the product’s label. Once an FDA-approved product is on the market, a doctor can prescribe it for other, “off-label” uses that were not specifically approved—but they can’t market the product for an off-label use . So, for example, in the course of prescribing minoxidil as a blood pressure pill, doctors noticed that their patients were growing more hair. The manufacturer did studies, went back to the FDA, and, voila--Rogaine®, which can be marketed to help hair growth.

The NxStage System One, Fresenius 2008K@home, and other machines have received FDA-approval for home use—but no machine has yet been approved specifically for nocturnal home HD. (You can read a 2008 FDA guidance document here). And, although a doctor can prescribe longer treatments using these machines, they cannot be marketed for nocturnal home HD. NxStage applied for a new indication for nocturnal dialysis, and Fresenius followed suit. And then, we waited. And waited. And, we are still waiting. Ironically, the FDA wants to encourage the development of innovative medical technologies—yet delays approval of an innovative therapy that improves lives.

What’s happened in those four years is that the large dialysis providers, on the advice of their attorneys, have pulled back so far on nocturnal home HD that they are not even allowed to use the phrase “nocturnal home HD.” We have to say “extended” home HD instead to mean longer dialysis (because dialysis is not necessarily done at night while someone is sleeping).

On Home Dialysis Central, we track the numbers of home programs that offer each treatment option.Nocturnal home HD (NHHD) is the only option for which the numbers of programs have dropped over the past 4 years. In 2011, NHHD reached a high of 493 programs in the US. Today? Just 266.

Each home program has a “catchment area”. So, the loss of a couple of hundred programs means that there are many tens of thousands of people who no longer are within striking distance of a program that can offer them what is arguably the best dialysis of all.


I’m hoping to get good news soon about a nocturnal home HD indication (but, not holding my breath) . Meanwhile, let’s improve in-center nocturnal HD—currently the only officially sanctioned extended hemodialysis therapy. Even though we named our site Home Dialysis Central, we have always included in-center nocturnal as well, because it is, quite simply, better dialysis than standard in-center HD. (Naming the site Longerandorbetterdialysis.org was a bit much…). Lacson et al studied 655 people who had been on in-center nocturnal HD during 2007. Compared to standard in-center HD, those receiving nocturnal treatments had significantly fewer hospitalizations (48% vs. 59%), fewer hospital days (9.6 vs. 13.5), and a 10% survival advantage after adjustment for case mix and vascular access. i

growth in home dialysis

So, it’s truly unfortunate that scheduling of thrice-weekly in-center nocturnal HD tends to be a last priority, squeezed into the time between the last afternoon shift ends and the early morning one begins—typically from 8pm to 4am—which corresponds to normal sleep patterns in approximately NO ONE .

We know that many people on dialysis already have sleep issues:

  • One study found that 89% of people in the nondialysis CKD period reported sleep disorders. ii
  • Another estimated a sleep disorder rate of 80% for those with uremia—including insomnia, nighttime awakening, nightmares, restless legs syndrome, sleep apnea, etc.iii
  • DOPPS noted that sleep quality predicts quality of life and mortality. Among 11,351 people in 308 dialysis clinics in seven countries, almost 49% had poor self-reported sleep quality, which was associated with a 16% increase in the relative risk of mortality.

Correlation isn’t causation, of course. But, why not offer our best in-center option at a time that will allow people to have at least a fighting chance at a good night’s sleep? I also worry about people leaving a dialysis clinic at 4am, in the dark, especially in isolated or unsafe areas. A day shift for work would likely start at 6:30 at the earliest. What do people do between 4am and 6:30am?

In Singapore, the National Kidney Foundation is opening six new clinics, and will be offering in-center nocturnal—from 11 pm to 6 am. iv I’ve also heard of clinics in Canada and other countries that offer 10 pm – 6 am or 11 pm to 7 am shifts.

In-center folks who read this post (are there any?) will probably tell me that people like to have a daytime shift that starts at 5 am. I have to wonder if they really like it—or if it is just marginally better than other shifts later in the day. In general, having the better-staffed day shift take off the nocturnal folks and then starting the in-center treatment day at 6:30 or 7:00 am might be an improvement. It may be easier to find and retain staff, for example. The minority of folks on standard in-center HD who are able to keep their full-time jobs may truly prefer an ultra-early morning shift so they can dialyze before work—but if the 5 am shift moves to 7 am, it might make sense to offer an early evening shift for workers, who can then go home and to sleep if, for some reason, they don’t want to dialyze at night.

I’ve never run a dialysis clinic. But, to me, a patient-centered schedule might look something like this (with treatments staggered by 15 minutes for each shift so no one has to wait to get on the machine):

  • Morning shift : 7:00 - 11:00, 7:15 - 11:15, 7:30 - 11:30, 7:45 – 11:45
  • Late morning shift : 12:00 - 4:00, 12:15 – 4:15, 12:30– 4:30, 12:45 – 4:45
  • Afternoon shift : 5:00 – 9:00, 5:15 – 9:15, 5:30 – 9:30, 5:45 – 9:45
  • Night shift : 10:00 – 6:00, 10:15 – 6:15, 10:30 – 6:30, 10:45 – 6:45

Keep in mind that working people with employer group health plans contribute more than their share to your clinic’s bottom line. Think about setting up a schedule that will make it more likely for people to keep their jobs and health plans—and to get a good night’s sleep while they get better dialysis (and wait to go home).

i Lacson E, Wang W, Lester K, Ofsthun N, Lazarus JM, Hakim RM. Outcomes Associated with In-Center Nocturnal Hemodialysis from a Large Multicenter Program Clin J Am Soc Nephrol. Feb 2010; 5(2): 220–226.
ii De Santo RM , Cesare CM , Bartiromo M , Cirillo M . High prevalence of sleep disorders at the time of CKD diagnosis. J Ren Nutr. 2008 Jan;18(1):104-6.
iii Gusbeth-Tatomir P , Boisteanu D , Seica A , Buga C , Covic A . Sleep disorders: a systematic review of an emerging major clinical issue in renal patients. Int Urol Nephrol. 2007;39(4):1217-26..

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Comments

  • Dori

    Dec 22, 12:18 PM

    I don't know if griping publicly helped or not, but NxStage FINALLY has received FDA approval for nocturnal home HD! http://www.stockhouse.com/news/press-releases/2014/12/22/nxstage-receives-fda-clearance-for-home-nocturnal-hemodialysis

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  • Theodôr

    Nov 17, 6:31 AM

    Thanks Dory for the thorough article with the sad message that lawyer's rule medicin/ healthcare....

    What puzzles me is why/what the FDA takes so long to decide on this issue?
    Lack of expertise within the department which handles the request?

    Would it help when the patients association asks for their input?

    Just some thoughts....

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  • Lana

    Nov 13, 7:57 PM

    great post! send to FDA!

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    • Dori

      Nov 18, 8:05 AM

      That's a good idea, Lana! Maybe I will!

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